Labeling Recommendations for Hydrogen Peroxide-Based Contact Lens Care Products
This guidance applies to hydrogen peroxide-based contact lens care products (HPCPs) classified under 21 CFR 886.5918 and 21 CFR 886.5928. It provides labeling recommendations to promote safe and effective use of HPCPs and ensure consumers understand the benefits and risks, particularly due to serious eye injuries from product misuse.
What You Need to Know? 👇
What are the key labeling requirements for hydrogen peroxide-based contact lens care products in 510(k) submissions?
FDA recommends prominent red banners stating “DO NOT PUT IN EYES,” red caps/tips, three-panel bottle design, and standardized warnings about neutralization requirements. Package inserts must include detailed directions, contraindications, warnings about unneutralized solution risks, and consumer education about proper use with special cases only.
How should manufacturers address safety concerns related to hydrogen peroxide contact lens solution misuse?
Manufacturers should emphasize that solutions require special neutralizing cases (never flat cases), include minimum soaking times for neutralization, warn against direct eye contact, and provide clear graphics showing proper use. Bold warnings about severe burning/stinging from unneutralized solution are essential throughout all labeling components.
What specific warnings must be included on hydrogen peroxide contact lens care product labeling?
Critical warnings include: never use flat lens cases, minimum neutralization time requirements, prohibition of direct eye instillation, risks of severe burning/stinging, no reuse of neutralized solutions, and keeping products away from children. Additional warnings cover water exposure risks and proper lens care practices.
How does this FDA guidance differ from previous contact lens care product labeling recommendations?
This guidance specifically addresses hydrogen peroxide products due to increased adverse events from misuse. It supersedes previous recommendations by requiring prominent red visual cues, standardized warning formats, simplified language, and enhanced consumer education about neutralization processes that distinguish these products from multipurpose solutions.
What are the recommended design elements for hydrogen peroxide contact lens solution bottles and cartons?
FDA recommends red caps and tips, prominent red banners (minimum 1-inch height) with “DO NOT PUT IN EYES” messaging, three equal-sized bottle panels, and graphics showing proper/improper use. Carton flaps should include emphasized warnings against flat lens cases with accompanying visual symbols.
What consumer education elements should be included in hydrogen peroxide contact lens care product labeling?
Labeling should explain the neutralization process (one-step vs. two-step), describe how hydrogen peroxide works, provide step-by-step usage instructions with graphics, include lens case care information, and answer key consumer questions about proper use, risks, and emergency procedures for accidental eye exposure.
What You Need to Do 👇
Recommended Actions
- Review and update current product labeling to incorporate all recommended warning statements and formatting
- Implement prominent red warning banners on cartons and bottles
- Ensure bottle design includes red cap and tip
- Update package inserts to include all required sections with clear, simple language
- Add graphics to support key safety messages where appropriate
- Consider making labeling available on company website
- Evaluate labeling changes according to FDA’s guidance on when to submit a 510(k)
- Ensure all labeling components emphasize proper neutralization process and risks
- Implement distinct packaging to differentiate from other contact lens care products
- Include clear instructions for lens case care and replacement
Key Considerations
Human Factors
- Consumer labeling should be written in simple, plain language not exceeding eighth-grade reading level
- Use of graphics in device labeling is recommended to contribute to better comprehension
- Labeling should provide balanced presentation of adverse events, risks and benefits
Labelling
- Package insert must include detailed sections on: general instructions, product description, actions, indications, contraindications, warnings, precautions, adverse reactions, and directions for use
- Carton labeling should include prominent red banner with warnings about not putting solution in eyes
- Bottle labeling should have red cap and tip, with three equal-sized panels and prominent red warning banner
- All labeling components should emphasize the need for neutralization and risks of unneutralized solution
- Warning statements about not using flat lens cases should appear on carton flaps
Safety
- Must include warnings about risks of unneutralized hydrogen peroxide exposure
- Must specify minimum neutralization time before lens insertion
- Must warn against rinsing lenses with solution prior to insertion
- Must warn against direct application in eyes
Other considerations
- Manufacturers should consider placing consumer labeling on their website
- Bottle design should be distinct from other contact lens care products
- Storage case requirements must be specified
Relevant Guidances 🔗
- Deciding When to Submit a New 510k for Changes to an Existing Medical Device
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Device Labeling Requirements and Content for Premarket Approval Applications
Related references and norms 📂
- 21 CFR 801.60: Principal display panel requirements
- 21 CFR 801.61: Statement of identity requirements
- 21 CFR 801.62: Declaration of net quantity contents requirements
- 21 CFR 800.12: Contact lens solutions and tablets; tamper-resistant packaging
- 21 CFR 800.10: Contact lens solutions; sterility