OTC Product Development
Developing an OTC Product? Start With the Right Requirements.
Over the counter products require careful attention to formulation, active ingredients, manufacturing conditions, labeling, and regulatory requirements.
Sentara Labs evaluates selected nonsterile OTC topical product opportunities for businesses developing new products or seeking manufacturing solutions for existing formulations.
Our catalog includes potential products across acne care, skin protection, antiseptics, topical pain relief, antifungal treatments, medicated haircare, and sun protection.
OTC Product Categories
Product Concepts We Can Evaluate
Acne Care
Salicylic acid toners, acne spot treatment gels, benzoyl peroxide washes, sulfur cleansers, and selected acne creams.
First Aid & Antiseptics
Antiseptic liquids, alcohol solutions, hand antiseptic liquids and gels, and selected first aid concepts.
Skin Protectants
Petrolatum ointments, dimethicone creams and lotions, calamine lotions, and zinc oxide barrier pastes.
Topical Pain Relief
Selected menthol, camphor, capsaicin, and lidocaine topical product concepts.
Antifungal Treatments
Selected clotrimazole, miconazole, and tolnaftate creams or liquids.
Medicated Haircare
Qualifying anti dandruff shampoo concepts.
Sun Protection
Mineral sunscreen lotions and creams requiring appropriate formulation, testing, labeling, and regulatory qualification.
These examples are potential project categories, not confirmed finished stock or guarantees of manufacturing eligibility.
What an OTC Project Requires
Review the Product Before Planning Production
Regulatory Classification
Identify whether the intended product falls under cosmetic, OTC drug, or combined requirements.
Active Ingredients & Intended Use
Review the proposed ingredients, concentrations, indications, and applicable regulatory pathway.
Formulation Feasibility
Evaluate the proposed dosage form, ingredient compatibility, specifications, and manufacturing suitability.
Testing & Documentation
Identify requirements relevant to product stability, specifications, quality, and manufacturing records.
Labeling & Claims
Review intended product claims and applicable labeling obligations, including Drug Facts where required.
Manufacturing Qualification
Confirm whether the proposed product can be supported under the appropriate manufacturing and quality requirements.
Have an Existing OTC Formula?
Bring Your Specifications to the Conversation
If you already have an OTC product, include the details listed here.
These details help establish whether the project is appropriate for further review.
- Product category and intended indications
- Active ingredients and proposed concentrations
- Existing formula and specifications
- Current labeling or proposed claims
- Packaging requirements
- Estimated production quantity
- Any required testing or regulatory documentation
Starting With a Concept?
Build the Requirements Before the Product
If you're considering a new OTC product, the first step is understanding what regulatory pathway and technical requirements apply to the proposed product.
We can review the concept, identify questions that need to be resolved, and discuss whether the project aligns with available capabilities.
Have an OTC Formula or Product Concept?
Send us the product details, intended use, and estimated quantities so we can evaluate your inquiry.
All OTC opportunities are subject to product specific technical, manufacturing, labeling, and regulatory qualification. Catalog concepts do not represent confirmed inventory.