OTC Products 101: Launching a Compliant Product with Confidence

Thinking of launching an acne treatment, medicated shampoo, or SPF moisturizer? If your formula makes therapeutic claims, it likely qualifies as an OTC product and that means it’s regulated like a drug. Here’s what beauty brands need to know.

What Is an OTC Product?
Over-the-counter (OTC) products are non-prescription items that treat or prevent medical conditions. These include acne creams, dandruff shampoos, sunscreens, anti-fungal lotions, and more.

Why It Matters
Unlike standard cosmetics, OTC products must meet strict FDA regulations. That includes following established monographs or getting drug approval, plus manufacturing in a registered facility with full quality control.

Where ACRL Comes In
As an FDA-registered, GMP-compliant facility, ACRL helps beauty brands develop and manufacture OTC products that are compliant, safe, and effective. We handle:

• Monograph alignment
• Stability, micro, and compatibility testing
• Technical documentation and batch tracking
• Scalable production with built-in QA/QC

Examples of OTC Beauty Products We Manufacture

• Medicated shampoos and conditioners
• Acne spot treatments and cleansers
• SPF moisturizers and sunscreens
• Anti-fungal creams and body washes
• Hand sanitizers and oral care items

Final Word
If you’re developing a beauty product that crosses into OTC territory, the right partner makes all the difference. ACRL delivers the expertise and infrastructure to bring your product to market with clarity and confidence.

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