Medical Disclaimer
Last Updated: October 14, 2025
Operated by: Aqualanes Limited ("Aqualanes", "Company", "we", "our", or "us")
INTRODUCTION AND SCOPE OF APPLICATION
Aqualanes Limited operates the DERMXELL⁺ website, online store, and associated digital marketing channels (the "Services") to provide customers with premium cosmetic and anti-aging products. This Medical Disclaimer establishes clear medical and health-related disclaimers, advertising claim limitations, and safety guidelines for all DERMXELL⁺ products and associated cosmetic products distributed by Aqualanes Limited across all digital channels and international markets.
This Medical Disclaimer has been specifically designed to ensure comprehensive compliance with all major advertising platform health and wellness policies including AppLovin Corporation, Google LLC (including YouTube), Meta Platforms Inc. (Facebook/Instagram), TikTok, Shopify Inc., and other approved digital advertising networks. By accessing our Services, purchasing our products, or engaging with our advertising content across any platform, you acknowledge that you have read, understood, and accepted all medical disclaimers and health-related provisions contained herein.
CRITICAL ADVERTISING PLATFORM COMPLIANCE DECLARATION: This Medical Disclaimer ensures complete compliance with all major advertising platform health and wellness policies, medical claim restrictions, and therapeutic advertising limitations effective as of October 2025.
MANDATORY MEDICAL AND HEALTH DISCLAIMERS
2.1 PRIMARY MEDICAL DISCLAIMER (REQUIRED BY LAW) IMPORTANT MEDICAL DISCLAIMER: "These statements have not been evaluated by the Food and Drug Administration, Health Canada, European Medicines Agency, or any other medical regulatory authority. This product is not intended to diagnose, treat, cure, or prevent any disease, medical condition, or health disorder. DERMXELL⁺ products are cosmetic preparations for external use only and are not medical devices, pharmaceuticals, or therapeutic treatments."
2.2 COSMETIC PRODUCT CLASSIFICATION AND LIMITATIONS NON-MEDICAL PRODUCT DECLARATION: DERMXELL⁺ products are classified exclusively as cosmetic preparations under applicable cosmetic regulations and are NOT:
Medical devices requiring regulatory approval or clearance
Pharmaceuticals requiring prescription or medical supervision
Therapeutic goods making disease treatment or cure claims
Dietary supplements or nutraceuticals for internal consumption
Over-the-counter drugs with active pharmaceutical ingredients
Medical treatments for skin diseases, disorders, or medical conditions
2.3 HEALTH CONDITION AND MEDICAL TREATMENT DISCLAIMERS NO MEDICAL TREATMENT CLAIMS: DERMXELL⁺ products do not treat, cure, prevent, or diagnose any medical conditions including but not limited to:
Skin diseases, disorders, or dermatological medical conditions
Hormonal imbalances or endocrine system disorders
Allergic reactions, autoimmune conditions, or immune system disorders
Circulatory, cardiovascular, or vascular medical conditions
Neurological conditions, pain disorders, or chronic medical conditions
Any FDA-recognized disease, Health Canada-listed condition, or internationally recognized medical disorder
PLATFORM-SPECIFIC HEALTH AND WELLNESS COMPLIANCE
3.1 APPLOVIN CORPORATION HEALTH COMPLIANCE MANDATORY APPLOVIN HEALTH DISCLAIMER: "DERMXELL⁺ advertising through AppLovin's network strictly adheres to AppLovin's Health & Wellness advertising policies. We make no medical claims, disease treatment assertions, or therapeutic benefit representations. All product claims are limited to cosmetic appearance benefits only."
AppLovin-Specific Health Protections:
No medical targeting or health condition-based advertising
No sensitive health data collection or processing for advertising
No disease treatment, cure, or prevention claims in any advertising creative
Complete adherence to AppLovin's health advertising restrictions
Age-appropriate content with no targeting of users under 18 years of age
3.2 GOOGLE LLC AND YOUTUBE HEALTH COMPLIANCE GOOGLE HEALTH ADVERTISING COMPLIANCE: "DERMXELL⁺ advertising through Google Ads and YouTube strictly complies with Google's health and beauty product policies. All advertising claims are limited to cosmetic benefits and appearance enhancement only, with no medical efficacy or therapeutic outcome representations."
Google-Specific Health Limitations:
No health condition targeting or medical demographic advertising
No therapeutic benefit claims or medical outcome promises
No disease treatment representations in search or video advertising
Complete compliance with Google's health product advertising restrictions
Age-appropriate advertising with no targeting of users under 18 years of age
YouTube Health Content Standards:
All video content complies with YouTube's health and wellness content restrictions
No medical advice or therapeutic guidance provided in video content
Clear cosmetic-only benefit representations in all video advertising
Enhanced transparency measures for health-related content
3.3 META PLATFORMS (FACEBOOK/INSTAGRAM) HEALTH COMPLIANCE META HEALTH & WELLNESS DATA RESTRICTIONS (2025): MANDATORY COMPLIANCE DECLARATION: "We strictly comply with Meta's enhanced health and wellness data restrictions effective January 2025. We expressly do not make medical claims, target based on health conditions, or represent therapeutic benefits in any Facebook or Instagram advertising."
- Meta-Specific Health Protections:
- Complete exclusion of health-related targeting from all advertising campaigns
- No medical condition, health status, or wellness behavior targeting
- No therapeutic benefit representations in social media advertising
- Enhanced health data protection and complete health category exclusion
- Cosmetic-only benefit claims in all Facebook and Instagram advertising
- Meta Platform Health Standards:
- Facebook and Instagram advertising complies with Meta Community Standards for health content
- No before/after imagery implying medical transformation or therapeutic results
- Clear distinction between cosmetic benefits and medical claims in all creative content
- Enhanced user control mechanisms for health-related advertising preferences
3.4 SHOPIFY PLATFORM HEALTH COMPLIANCE SHOPIFY MERCHANT HEALTH COMPLIANCE: "All e-commerce operations and product representations through Shopify platform comply with Shopify's Acceptable Use Policy regarding health products and medical claims. Product descriptions and customer communications are limited to cosmetic benefits only."
Shopify-Specific Health Standards:
- Product pages comply with Shopify's health product representation requirements
- Customer service communications avoid medical advice or therapeutic guidance
- Order confirmation and shipping communications maintain cosmetic-only positioning
- Payment processing compliance with health product merchant standards
COMPREHENSIVE HEALTH AND SAFETY WARNINGS
4.1 INDIVIDUAL HEALTH VARIATION AND RESULTS DISCLAIMER CRITICAL HEALTH ACKNOWLEDGMENT: "Individual results from DERMXELL⁺ products may vary significantly based on personal health factors, genetic predisposition, skin condition, age, lifestyle, medical history, and adherence to usage instructions. No cosmetic product can guarantee specific results or outcomes for all users."
- Health-Related Result Variation Factors:
- Individual genetic predisposition and family history
- Current health status and medical conditions
- Medication use affecting skin condition and sensitivity
- Hormonal status and endocrine system factors
- Environmental exposure and lifestyle factors
- Age-related skin changes and natural aging processes
4.2 MEDICAL CONSULTATION REQUIREMENTS MANDATORY MEDICAL CONSULTATION DISCLAIMER: "Consult with qualified healthcare professionals before using DERMXELL⁺ products if you have any of the following conditions or circumstances:"
Required Medical Consultation Conditions:
- Pregnancy, nursing, or planning pregnancy
- Active skin diseases, disorders, or dermatological conditions
- Known allergies or sensitivities to cosmetic ingredients
- Current use of prescription skincare medications or treatments
- History of severe allergic reactions or autoimmune conditions
- Cancer treatment, chemotherapy, or radiation therapy
- Chronic medical conditions affecting skin health or healing
- Recent cosmetic procedures or professional skin treatments
4.3 CONTRAINDICATIONS AND USAGE WARNINGS IMPORTANT SAFETY CONTRAINDICATIONS: "Do not use DERMXELL⁺ products under the following circumstances:"
Absolute Contraindications:
- Open wounds, cuts, or broken skin in application area
- Active skin infections, rashes, or inflammatory conditions
- Known allergies to any listed ingredient
- Severe eczema, dermatitis, or chronic skin conditions
- Recent professional chemical peels or laser treatments
- Current use of prescription retinoids without professional guidance
Safety Usage Warnings:
- For external use only - never ingest or apply to mucous membranes
- Avoid direct contact with eyes, lips, or sensitive areas
- Discontinue use immediately if irritation, redness, or adverse reactions occur
- Keep out of reach of children and pets
- Store in cool, dry place away from direct sunlight
MEDICAL EMERGENCY AND ADVERSE REACTION PROTOCOLS
5.1 IMMEDIATE RESPONSE TO ADVERSE REACTIONS EMERGENCY RESPONSE PROTOCOL: "If you experience any of the following serious reactions, discontinue use immediately and seek emergency medical attention:"
Emergency Medical Attention Required:
- Severe allergic reactions including difficulty breathing, widespread rash, or swelling
- Immediate skin burning, blistering, or severe irritation
- Signs of chemical burns or tissue damage
- Systemic allergic reactions affecting multiple body systems
- Any reaction that worsens rapidly or does not improve within 24 hours
Immediate Response Actions:
- Discontinue product use immediately
- Rinse affected area thoroughly with cool water
- Do not apply any other products to affected area
- Document reaction with photos and timeline
- Seek professional medical evaluation for persistent or severe reactions
5.2 ADVERSE REACTION REPORTING REQUIREMENTS REGULATORY REPORTING OBLIGATIONS: "Serious adverse reactions must be reported to appropriate regulatory authorities and Aqualanes Limited for safety monitoring and compliance purposes."
Required Reporting Procedures:
- Report serious adverse reactions to support@dermxell.com within 24 hours
- Include detailed reaction description, timeline, and photographic documentation
- Provide complete product usage history and batch number information
- Cooperate with regulatory authority reporting requirements when necessary
- Follow up with medical documentation when professional treatment is sought
Regulatory Authority Reporting:
- United States: FDA MedWatch Program (www.fda.gov/medwatch)
- Canada: Health Canada Cosmetic Incident Reporting (www.canada.ca/en/health-canada/services/consumer-product-safety)
- European Union: National competent authority in country of residence
- Other Jurisdictions: Relevant national cosmetic safety authorities
5.3 MEDICAL PROFESSIONAL COORDINATION HEALTHCARE PROVIDER COMMUNICATION: "If you experience adverse reactions requiring medical attention, inform your healthcare provider about DERMXELL⁺ product usage and provide ingredient information for proper medical evaluation."
Medical Professional Coordination:
- Provide complete ingredient list to treating healthcare providers
- Share usage timeline and application frequency information
- Document all medical treatments received for adverse reactions
- Follow medical professional guidance regarding continued product use
- Maintain records of all medical consultations related to product use
PREGNANCY, NURSING, AND SPECIAL POPULATIONS
6.1 PREGNANCY AND NURSING SAFETY DISCLAIMERS PREGNANCY AND NURSING WARNING: "The safety of DERMXELL⁺ products during pregnancy and nursing has not been established through clinical testing. Pregnant and nursing women should consult healthcare providers before using any cosmetic products."
Pregnancy-Specific Considerations:
- Hormonal changes during pregnancy may increase skin sensitivity
- Unknown effects of cosmetic ingredients on fetal development
- Potential for increased absorption through altered skin barrier
- Risk of allergic sensitization during pregnancy
- Need for healthcare provider guidance on cosmetic product safety
Nursing Safety Considerations:
- Potential for ingredient transfer to nursing infants
- Unknown safety of cosmetic ingredients for nursing mothers
- Risk of allergic reactions during hormonal changes
- Need for pediatric safety consideration
- Healthcare provider guidance recommended for all cosmetic use
6.2 PEDIATRIC SAFETY AND AGE RESTRICTIONS PEDIATRIC SAFETY WARNING: "DERMXELL⁺ products are formulated exclusively for adult use (18 years and older). These products are not suitable for children, adolescents, or minors under any circumstances."
Age-Related Safety Considerations:
- Adult formulations not appropriate for developing skin
- Potential for increased sensitivity in younger populations
- Unknown safety profiles for pediatric use
- Risk of hormonal or developmental interference
- Legal and regulatory restrictions on cosmetic use for minors
Child Safety Measures:
- Keep all products out of reach of children and pets
- Secure storage in adult-only accessible locations
- Immediate medical attention if accidental ingestion occurs
- Clear labeling indicating adult-only usage
- Education of adults regarding child safety responsibilities
6.3 ELDERLY AND COMPROMISED HEALTH POPULATIONS SPECIAL POPULATION CONSIDERATIONS: "Elderly individuals and those with compromised health conditions should exercise additional caution and seek medical guidance before using DERMXELL⁺ products."
Elderly Population Considerations:
- Age-related changes in skin barrier function and sensitivity
- Potential medication interactions with cosmetic ingredients
- Increased risk of allergic reactions or sensitivities
- Need for gentle application and monitoring
- Healthcare provider consultation recommended
Compromised Health Population Warnings:
- Individuals with autoimmune conditions require medical clearance
- Cancer patients and those undergoing treatment need oncologist approval
- Individuals with diabetes should monitor for delayed healing or complications
- Those with circulation disorders require enhanced monitoring
- Immunocompromised individuals need medical supervision
INGREDIENT SAFETY AND ALLERGY DISCLAIMERS
7.1 INGREDIENT SAFETY TRANSPARENCY INGREDIENT SAFETY DISCLOSURE: "While DERMXELL⁺ products are formulated with carefully selected cosmetic-grade ingredients, individual allergic reactions and sensitivities can occur with any cosmetic product."
Ingredient Safety Considerations:
- All ingredients are cosmetic-grade and regulatory compliant
- Individual allergic reactions cannot be completely prevented
- Patch testing recommended before full application
- Ingredient sensitivities may develop over time
- Cross-reactivity with other products possible
Common Sensitivity Indicators:
- Previous allergic reactions to cosmetic products
- Sensitive skin history or dermatologist-diagnosed sensitivity
- Multiple chemical sensitivities or environmental allergies
- History of contact dermatitis or eczema
- Seasonal or environmental allergy patterns
7.2 PATCH TESTING REQUIREMENTS AND PROCEDURES MANDATORY PATCH TESTING RECOMMENDATION: "Perform patch testing before first use of DERMXELL⁺ products to identify potential allergic reactions or sensitivities."
Patch Testing Procedures:
- Apply small amount to inner forearm or behind ear
- Leave undisturbed for 24-48 hours
- Monitor for redness, swelling, itching, or irritation
- Do not use product if any adverse reaction occurs during patch testing
- Wait additional 24 hours after patch test before full application
- Enhanced Patch Testing for High-Risk Individuals:
- Extended 72-hour patch testing for sensitive skin individuals
- Multiple site testing for those with allergy history
- Professional dermatological patch testing for severe sensitivity history
- Documentation of patch test results for future reference
- Medical professional guidance for individuals with extensive allergy history
7.3 INGREDIENT INTERACTION AND COMPATIBILITY WARNINGS PRODUCT INTERACTION DISCLAIMER: "DERMXELL⁺ products may interact with other skincare products, medications, or treatments. Consult healthcare providers regarding product compatibility."
Potential Interaction Considerations:
- Prescription skincare medications (retinoids, antibiotics, steroids)
- Over-the-counter acne treatments or exfoliating products
- Professional skincare treatments or procedures
- Other cosmetic products with active ingredients
- Oral medications affecting skin sensitivity
- Interaction Prevention Measures:
- Inform healthcare providers of all cosmetic product use
- Space application of different products appropriately
- Monitor for increased sensitivity when combining products
- Discontinue use if unusual reactions occur
- Seek professional guidance for complex skincare routines
PROFESSIONAL MEDICAL TREATMENT AND COSMETIC LIMITATIONS
8.1 COSMETIC VERSUS MEDICAL TREATMENT DISTINCTIONS COSMETIC LIMITATION DECLARATION: "DERMXELL⁺ products provide cosmetic benefits only and should not be considered substitutes for professional medical treatment, dermatological care, or therapeutic interventions."
Clear Cosmetic Boundaries:
- Cosmetic products enhance appearance but do not treat medical conditions
- Professional dermatological care required for skin diseases or disorders
- Medical treatments necessary for therapeutic outcomes
- Cosmetic benefits limited to temporary appearance enhancement
- No replacement for professional medical diagnosis or treatment
Medical Treatment Priority:
- Seek professional medical care for persistent skin concerns
- Do not delay medical treatment while using cosmetic products
- Inform healthcare providers of all cosmetic product usage
- Follow medical professional guidance regarding cosmetic product use
- Prioritize medical treatment over cosmetic routines when health issues arise
8.2 DERMATOLOGICAL CONSULTATION RECOMMENDATIONS DERMATOLOGICAL GUIDANCE DISCLAIMER: "Individuals with skin concerns, sensitivities, or conditions should consult qualified dermatologists before using DERMXELL⁺ products."
Dermatological Consultation Indicators:
- Chronic skin conditions or recurring skin problems
- Unusual skin changes or new skin lesions
- History of severe allergic reactions to cosmetic products
- Current dermatological treatment or professional care
- Uncertainty about skin type or appropriate product selection
Professional Dermatological Services:
- Comprehensive skin assessment and diagnosis
- Professional product recommendation and compatibility evaluation
- Medical treatment for skin diseases or disorders
- Ongoing monitoring of skin health and cosmetic product effects
- Emergency care for severe allergic reactions or complications
8.3 COSMETIC SURGERY AND PROFESSIONAL PROCEDURE CONSIDERATIONS PROFESSIONAL PROCEDURE COMPATIBILITY: "Individuals who have undergone or are planning cosmetic procedures should consult with their healthcare providers regarding DERMXELL⁺ product use and timing."
Procedure Compatibility Considerations:
- Post-surgical skin sensitivity and healing requirements
- Potential interference with healing processes
- Risk of infection or complication from cosmetic product use
- Professional guidance needed for post-procedure skincare
- Timing considerations for resuming cosmetic product use
Required Professional Clearance:
- Recent cosmetic surgery or dermatological procedures
- Active healing from professional treatments
- Planned procedures requiring pre-treatment preparation
- Ongoing professional skincare treatment programs
- Any procedure affecting skin barrier function or sensitivity
INTERNATIONAL HEALTH REGULATIONS AND COMPLIANCE
9.1 GLOBAL HEALTH REGULATORY COMPLIANCE INTERNATIONAL REGULATORY DISCLAIMER: "DERMXELL⁺ products comply with cosmetic regulations in distribution jurisdictions but may not meet medical device or pharmaceutical standards in all countries."
International Regulatory Considerations:
- Product classification varies by jurisdiction
- Medical claims prohibited under international cosmetic regulations
- Import restrictions may apply in certain countries
- Local health authorities may have additional requirements
- Customers responsible for compliance with local regulations
Jurisdictional Compliance Standards:
- United States: FDA cosmetic regulations and FTC advertising guidelines
- European Union: EU Cosmetic Regulation (EC) No 1223/2009
- Canada: Health Canada cosmetic regulations and safety standards
- Australia: Therapeutic Goods Administration cosmetic requirements
- Other jurisdictions: Local cosmetic safety and advertising regulations
9.2 IMPORT HEALTH DOCUMENTATION AND RESTRICTIONS INTERNATIONAL IMPORT HEALTH COMPLIANCE: "International customers are responsible for ensuring DERMXELL⁺ products comply with destination country health and cosmetic import regulations."
Import Health Considerations:
- Customs health documentation requirements
- Destination country cosmetic ingredient restrictions
- Local health authority approval requirements
- Prohibited ingredient lists in destination countries
- Health certificate or safety documentation needs
Customer Import Responsibilities:
- Verify legal import status of cosmetic products
- Obtain required health documentation or certificates
- Comply with local customs health reporting requirements
- Accept responsibility for prohibited ingredient violations
- Coordinate with local health authorities when required
9.3 CROSS-BORDER HEALTH EMERGENCY PROTOCOLS INTERNATIONAL HEALTH EMERGENCY PROCEDURES: "International customers experiencing health emergencies related to DERMXELL⁺ products should seek local medical attention immediately and notify both local health authorities and Aqualanes Limited."
International Emergency Response:
- Contact local emergency medical services immediately
- Report adverse reactions to local health authorities
- Notify Aqualanes Limited of international health emergencies
- Provide product information to treating healthcare providers
- Coordinate with international regulatory reporting requirements
Cross-Border Medical Coordination:
- Facilitate communication between local and origin country authorities
- Provide product safety information to international healthcare providers
- Cooperate with cross-border health investigations
- Maintain documentation for international regulatory compliance
- Support customer access to medical care and information
COMPREHENSIVE LIABILITY LIMITATIONS AND HEALTH DISCLAIMERS
10.1 HEALTH-RELATED LIABILITY LIMITATIONS MAXIMUM HEALTH LIABILITY DISCLAIMER: "Aqualanes Limited's total liability for any health-related claims arising from DERMXELL⁺ products shall not exceed the purchase price of the specific product, and excludes all medical expenses, health consequences, or therapeutic expectations."
Health Liability Exclusions:
- Medical treatment costs resulting from product use
- Healthcare expenses for adverse reactions or complications
- Lost time, wages, or opportunities due to health effects
- Pain and suffering from allergic reactions or sensitivities
- Long-term health consequences or chronic conditions
- Punitive damages for health-related product issues
Health Outcome Disclaimers:
- No guarantee of specific health outcomes or improvements
- No warranty of compatibility with individual health conditions
- No assurance of safety for specific medical circumstances
- No representation of therapeutic benefit or medical efficacy
- No promise of prevention of health problems or aging processes
10.2 MEDICAL PROFESSIONAL LIABILITY LIMITATIONS MEDICAL ADVICE LIMITATION DISCLAIMER: "Aqualanes Limited does not provide medical advice, diagnosis, or treatment recommendations. All health-related guidance must be obtained from qualified healthcare professionals."
Medical Advice Limitations:
- Customer service representatives are not medical professionals
- Product information is not medical advice or therapeutic guidance
- Usage instructions are cosmetic application guidelines only
- No medical diagnosis or treatment recommendations provided
- Healthcare professionals must be consulted for medical concerns
Professional Medical Responsibility:
- Customers responsible for obtaining appropriate medical care
- Healthcare providers responsible for medical advice and treatment
- Medical professionals must evaluate cosmetic product compatibility
- Patient-physician relationship takes precedence over cosmetic use
- Medical emergencies require immediate professional medical attention
10.3 HEALTH CONDITION AND MEDICAL TREATMENT DISCLAIMERS MEDICAL CONDITION COMPATIBILITY DISCLAIMER: "DERMXELL⁺ products are not formulated for specific medical conditions and may not be appropriate for individuals with health disorders, medical treatments, or therapeutic regimens."
Medical Condition Considerations:
- Products not tested for compatibility with specific medical conditions
- Unknown interactions with medical treatments or medications
- Potential interference with therapeutic regimens or healing processes
- Risk of complication for individuals with compromised health
- Need for medical clearance for individuals with health conditions
Medical Treatment Interference:
- Possible interaction with prescription medications
- Potential interference with medical procedures or treatments
- Risk of complication during medical treatment periods
- Unknown effects on healing or recovery processes
- Medical professional guidance required for treatment compatibility
CONSUMER EDUCATION AND HEALTH LITERACY
11.1 HEALTH INFORMATION AND EDUCATIONAL RESOURCES HEALTH EDUCATION DISCLAIMER: "Health and safety information provided by DERMXELL⁺ is for educational purposes only and should not be considered medical advice or substitute for professional healthcare guidance."
Educational Resource Limitations:
- Information provided for general educational purposes only
- Not intended as personalized medical advice or treatment guidance
- Should not replace consultation with qualified healthcare professionals
- May not address individual health circumstances or conditions
- Requires professional medical interpretation for specific situations
Consumer Health Responsibility:
- Consumers responsible for seeking appropriate medical care
- Individual responsibility for understanding personal health needs
- Professional medical consultation required for health concerns
- Personal responsibility for monitoring health effects of cosmetic use
- Education about when to seek professional medical attention
11.2 HEALTH LITERACY AND INFORMED CONSUMER CHOICES INFORMED CONSUMER DISCLAIMER: "Consumers are responsible for understanding their own health conditions, sensitivities, and limitations when choosing to use DERMXELL⁺ products."
Informed Consumer Responsibilities:
- Understanding personal health history and medical conditions
- Awareness of allergies, sensitivities, and contraindications
- Knowledge of current medications and potential interactions
- Recognition of when professional medical consultation is needed
- Ability to monitor for adverse reactions and seek appropriate care
Health Literacy Requirements:
- Basic understanding of cosmetic versus medical products
- Awareness of when cosmetic products are not appropriate
- Knowledge of proper usage and safety precautions
- Understanding of when to discontinue use and seek medical care
- Ability to communicate health concerns to healthcare providers
REGULATORY AUTHORITY COORDINATION AND REPORTING
12.1 HEALTH AUTHORITY REPORTING AND COMPLIANCE REGULATORY HEALTH REPORTING DISCLAIMER: "Aqualanes Limited cooperates fully with health authorities regarding cosmetic safety reporting and regulatory compliance but cannot guarantee regulatory interpretation or enforcement decisions."
Health Authority Coordination:
- Full cooperation with FDA, Health Canada, EMA, and other health authorities
- Timely reporting of adverse reactions and safety concerns
- Compliance with regulatory health and safety requirements
- Participation in health authority investigations and assessments
- Adherence to regulatory guidance and enforcement actions
Regulatory Compliance Limitations:
- Cannot guarantee regulatory interpretation of product classification
- Regulatory requirements may change affecting product availability
- Health authority decisions may impact product distribution
- Regulatory compliance does not guarantee individual safety outcomes
- Health authority approval does not ensure compatibility with all users
12.2 HEALTH DATA REPORTING AND DOCUMENTATION HEALTH DATA COLLECTION DISCLAIMER: "Health-related data collection is limited to safety monitoring and regulatory compliance purposes and does not constitute medical record keeping or healthcare service provision."
Health Data Collection Limitations:
- Data collection limited to cosmetic safety monitoring
- Information not maintained as medical records
- Data sharing with health authorities for regulatory compliance only
- No medical analysis or diagnostic interpretation provided
- Professional medical records required for healthcare purposes
Health Information Sharing:
- Adverse reaction reports shared with regulatory authorities when required
- Customer health information protected according to privacy regulations
- Medical information requires customer consent for sharing
- Health data used only for safety monitoring and regulatory compliance
- No medical advice or interpretation provided based on collected data
FORCE MAJEURE AND HEALTH EMERGENCY PROVISIONS
13.1 PUBLIC HEALTH EMERGENCY PROVISIONS PUBLIC HEALTH EMERGENCY DISCLAIMER: "During public health emergencies, DERMXELL⁺ product availability, shipping, and customer service may be affected, and health guidance may require updates based on evolving health authority recommendations."
Public Health Emergency Considerations:
- Product availability may be affected by health emergency restrictions
- Shipping and delivery may be impacted by health authority requirements
- Customer service response times may be extended during health emergencies
- Health guidance may require updates based on evolving regulations
- Emergency health protocols take precedence over standard operations
Health Emergency Response:
- Immediate compliance with health authority emergency requirements
- Priority customer communication regarding health emergency impacts
- Enhanced safety protocols during public health emergencies
- Coordination with health authorities for emergency health guidance
- Adaptation of operations to maintain health and safety standards
13.2 HEALTH SUPPLY CHAIN AND CONTINUITY PROVISIONS HEALTH SUPPLY CHAIN DISCLAIMER: "Health emergency disruptions may affect DERMXELL⁺ product supply, quality control, and safety monitoring capabilities, requiring enhanced consumer vigilance and professional health guidance."
Supply Chain Health Considerations:
- Raw material availability may be affected by health emergencies
- Quality control procedures may require modification during health crises
- Safety monitoring capabilities may be limited during health emergencies
- Professional health consultation may be more critical during disruptions
- Enhanced consumer responsibility for health monitoring during emergencies
Health Continuity Planning:
- Alternative supply chain arrangements for critical safety components
- Enhanced communication protocols during health emergency disruptions
- Priority allocation of products for health-critical applications
- Coordination with health authorities for supply chain health guidance
- Emergency procedures for maintaining product safety and quality
CONTACT INFORMATION AND HEALTH EMERGENCY PROCEDURES
14.1 HEALTH EMERGENCY CONTACT PROCEDURES HEALTH EMERGENCY CONTACT INFORMATION: Immediate Health Emergencies: Contact local emergency medical services (911 in US, 999 in UK, 000 in Australia) Aqualanes Limited Health Safety Department: Email: support@dermxell.com (Subject: "Health Emergency") Emergency Phone: +852 6516 5836 Business Hours: Monday-Friday, 9 AM - 5 PM Hong Kong Time (HKT)
14.2 REGULATORY HEALTH AUTHORITY CONTACTS United States Health Authorities:
- FDA Consumer Complaints: www.fda.gov/safety/report-problem-fda
- FDA MedWatch: www.fda.gov/medwatch (for serious adverse reactions)
- Poison Control: 1-800-222-1222 (for accidental ingestion)
International Health Authorities:
- Health Canada: www.canada.ca/en/health-canada/services/consumer-product-safety
- European Commission (CPNP): ec.europa.eu/growth/tools-databases/cpnp
- UK MHRA: yellowcard.mhra.gov.uk (for adverse reactions)
- Australia TGA: www.tga.gov.au/reporting-adverse-events
14.3 SPECIALIZED HEALTH SUPPORT SERVICES Non-Emergency Health Concerns: Email: support@dermxell.com (Subject: "Health Concern - [Order Number]") Include: Complete health concern description, product usage details, medical history relevant to concern Response timeline: Priority processing within 4 hours during business hours
Adverse Reaction Reporting: Email: support@dermxell.com (Subject: "Adverse Reaction Report - [Order Number]") Include: Detailed reaction description, photos if applicable, timeline, medical treatment received Response timeline: Immediate escalation within 2 hours
Medical Professional Inquiries: Email: support@dermxell.com (Subject: "Medical Professional Inquiry") Include: Professional credentials, patient concern, specific medical questions Response timeline: Within 24 hours with appropriate medical documentation
POLICY UPDATES AND HEALTH REGULATION CHANGES
15.1 HEALTH REGULATION UPDATE PROCEDURES HEALTH REGULATION COMPLIANCE UPDATES: "This Medical Disclaimer may be updated to reflect changes in health regulations, medical research, platform policies, or safety information affecting DERMXELL⁺ products."
Health Regulation Update Process:
- Immediate implementation for urgent health and safety requirements
- 30-day advance notice for non-urgent health regulation changes
- Enhanced notification for changes affecting consumer health and safety
- Medical professional consultation for significant health guidance updates
- Regulatory authority coordination for compliance requirement changes
Health Information Updates:
- Incorporation of new safety data or medical research
- Updates based on adverse reaction patterns or safety monitoring
- Regulatory requirement changes affecting health disclaimers
- Platform policy updates affecting health and wellness content
- International health regulation changes affecting global distribution
15.2 CONTINUOUS HEALTH MONITORING AND IMPROVEMENT ONGOING HEALTH SAFETY MONITORING: "Aqualanes Limited maintains continuous health safety monitoring and improvement programs to enhance consumer protection and regulatory compliance."
Health Safety Monitoring:
- Ongoing adverse reaction monitoring and analysis
- Regular safety data review and assessment
- Continuous regulatory compliance monitoring
- Industry best practice integration for health safety
- Consumer feedback integration for health safety improvements
Health Safety Improvement:
- Regular medical professional consultation for safety enhancements
- Integration of new health research and safety data
- Enhanced consumer education and health literacy programs
- Improved health emergency response procedures
- Advanced health monitoring and reporting systems
LEGAL VALIDITY AND ENFORCEABILITY
16.1 DOCUMENT AUTHORITY AND LEGAL EFFECT This Medical Disclaimer becomes effective immediately upon publication and supersedes all previous versions. This document constitutes a legally binding agreement between Aqualanes Limited and all users of DERMXELL⁺ products and services regarding health-related disclaimers, medical limitations, and safety requirements.
Legal Enforceability: Should any provision of this Medical Disclaimer be deemed invalid, illegal, or unenforceable by a court of competent jurisdiction, such provision shall be severed, and the remainder of the document shall remain in full force and effect.
16.2 INTEGRATION WITH COMPREHENSIVE LEGAL FRAMEWORK Complete Legal Framework: This Medical Disclaimer, together with our Privacy Policy, Terms of Service, FDA Disclaimer, Data Privacy Rights document, Ingredient Safety Guidelines, Cookie Policy, Refund & Return Policy, and Shipping Policy, constitutes the complete legal and operational framework governing DERMXELL⁺ products and services.
Policy Hierarchy: In the event of conflicts between health-related provisions across multiple policy documents, the most protective provision for consumer health and safety and the most compliant provision with applicable health regulations shall prevail.
Translation Disclaimer: In the event of conflicts between translated versions of this Medical Disclaimer, the English language version shall control and supersede all other versions.
DOCUMENT AUTHENTICATION AND CERTIFICATION
Document Version: October 14, 2025, 001
Legal Review Date: October 14, 2025
Medical Review Date: October 14, 2025
Next Scheduled Review: January 14, 2026 Regulatory Compliance Status: Current as of October 2025
This Medical Disclaimer has been prepared to meet the highest standards of health regulatory compliance, advertising platform policy adherence, and international legal protection for global health and safety operations. For specific medical disclaimer questions or complex health regulatory implementations, consult with qualified legal and medical counsel familiar with health product regulations and international cosmetic safety law.
Final Notice: This Medical Disclaimer provides comprehensive health and safety information but does not replace professional medical advice. Consumers should always consult qualified healthcare professionals for medical concerns, health conditions, or questions about product compatibility with individual health circumstances.
Postal Address: Aqualanes Limited
Medical Disclaimer Office: Flat/Rm C1207 12/F, Hang Cheong Factory Building 1 Wing Ming Street, Cheung Sha Wan, Kowloon Hong Kong