FDA Registration for Acne Drug Products
Acne drug products containing benzoyl peroxide, salicylic acid, or sulfur are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration, NDC labeler code, and drug listing.
FDA Requirements for Acne Drug Products
Acne drug products are regulated as over-the-counter (OTC) drugs under FDA’s OTC Monograph system. The active ingredients permitted in OTC acne drug products include benzoyl peroxide (2.5–10%), salicylic acid (0.5–2%), and sulfur (3–10%).
All manufacturers of OTC acne drug products must: (1) Register their drug establishment with FDA, (2) Obtain an NDC Labeler Code, (3) List each acne product with FDA in SPL format with Drug Facts labeling.
- FDA Drug Establishment Registration — required for manufacturers, repackers, re-labelers
- NDC Labeler Code — unique identifier required for all acne drug products
- Drug Listing in SPL Format — with Drug Facts panel uploaded
- Annual Renewal — October 1–December 31 each year
- GMP Compliance — 21 CFR Parts 210 & 211
Over-the-counter (OTC) acne products are regulated by the FDA through a monograph system. This means there are specific rules manufacturers must follow to ensure their products are safe and effective. These rules cover things like the types and concentrations of ingredients allowed in the product, as well as the labeling. There are five ingredients currently approved for OTC acne treatment: benzoyl peroxide, salicylic acid, sulfur, and combinations of resorcinol or resorcinol monoacetate with sulfur. These ingredients work in various ways to combat acne such as reducing the number of acne pimples, blackheads or whiteheads and and allows skin to heal.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Benzoyl peroxide, 2.5 to 10 percent | M006.10 (Part 333) |
| Resorcinol, 2 percent, when combined with sulfur | M006.10 (Part 333) |
| Resorcinol monoacetate, 3 percent, when combined with sulfur | M006.10 (Part 333) |
| Salicylic acid, 0.5 to 2 percent | M006.10 (Part 333) |
| Sulfur, 3 to 10 percent | M006.10 (Part 333) |
| Sulfur, 3 to 8 percent when combined with resorcinol or resorcinol monoacetate | M006.10 (Part 333) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
Salicylic acid at 0.5 to 2 percent is the range most often asked about. A product formulated above 2 percent salicylic acid falls outside OTC Monograph M006 and cannot be marketed as an OTC acne drug under it.
Required Labeling Under the Acne Monograph
Conforming to the ingredient limits is only half of it. The monograph also fixes what the label must say, and a compliant formula with non-compliant labeling is still a misbranded product.
Indications
The label must state that the product is for the management or treatment of acne. Optional additional claims are permitted, such as clearing acne blemishes or helping prevent new blackheads and pimples.
Warnings
- All products: “For external use only.”
- All products: a caution against using other topical acne medications at the same time unless directed by a doctor.
- Sulfur products: do not apply to broken skin or to large areas of the body.
- Benzoyl peroxide: sensitivity warnings, increased sun sensitivity, and a caution that the product may bleach hair or dyed fabric.
- Combination products: instructions on avoiding contact with the eyes.
Directions
The monograph directions require cleaning the skin thoroughly before applying, then covering the affected area with a thin layer one to three times daily, starting with one application a day and increasing gradually if drying or peeling occurs.
What the Monograph Means for Registration
Meeting M006 does not exempt you from registration. Any establishment that manufactures, packages or labels an OTC acne product for the US market must register with FDA and list the product, and OTC monograph drug facilities may owe annual OMUFA facility fees. Current amounts are on our FDA fees page.
- Facility registration and product listing through the FDA Electronic Submissions Gateway – see the OTC drug registration process.
- An NDC number for each listed product.
- A US Agent if the manufacturing site is outside the United States.
- Annual renewal between October 1 and December 31 – see drug establishment registration renewal.
A formula that falls outside the monograph – salicylic acid above 2 percent, or an active ingredient not listed above – is not an OTC monograph drug and requires a different route to market.
Acne Drug Products — FAQs
Are acne products drugs or cosmetics?
What is the OTC Monograph for acne products?
Do I need FDA registration to sell acne products in the USA?
Ready to Register Your Acne Drug Products?
LMG handles drug establishment registration, OTC drug listing, and NDC labeler code for acne drug products manufacturers worldwide.
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