Tamper-Evident Labels for OTC Drugs & Cosmetics

Tamper-Evident Labels for OTC Drugs & Cosmetics

Unlike general food packaging, tamper-evident packaging for over-the-counter drugs — and a narrower set of cosmetics — is a specific federal requirement, not just good practice.

General information, not legal advice — confirm current requirements with FDA guidance or your compliance counsel.

Tamper Evident Labels

Intertronix's Tamper Evident Labels, Void Stickers & Security Seals are used by pharmaceutical companies and pharmacies to seal bottles, cartons, and caps so any opening leaves visible, permanent evidence. No artwork approval required on stock items, and custom sizes/printing are available for regulated packaging runs.

Why it matters

FDA requires OTC drug packaging to carry a visible tamper-evident indicator or barrier (21 CFR 211.132), with a few exemptions (dermatologics, dentifrices, insulin, lozenges) — and the package must say what the tamper-evident feature is. Cosmetics carry a narrower version of the same rule: it applies specifically to liquid oral hygiene products and vaginal products (21 CFR 700.25), not cosmetics generally.

Not sure if your product falls under either rule? Our team can help you find the right seal — the compliance determination is always yours and your regulator's.

Sources: FDA 21 CFR 211.132 · FDA 21 CFR 700.25