Acne Treatment Cream

Acne Treatment Cream is an FDA-registered drug product whose active ingredient is BENZOYL PEROXIDE. It is labelled by CVS Health taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 51316-654, application M006, label effective 20260819. It is one of 56 FDA drug label records sharing the active ingredient BENZOYL PEROXIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BENZOYL PEROXIDE are most often described in connection with: treatment acne. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use(s) for the treatment of acne

Directions Directions • clean the skin thoroughly before applying this product • cover the entire affected area with a thin layer one to three times daily • because excessive drying of the skin may occur,start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor• if bothersome dryness or peeling occurs,reduce application to once a day or every other day • if going outside,apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Warnings For external use only For external use only Do not use • have very sensitive skin •are sensitive to benzoyl peroxide When using this product When using this product • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product •skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. Stop use and ask a doctor if if irritation becomes severe Pregnancy/Breastfeeding If pregnant or breastfeeding, ask a health professional before use Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately

FDA lists 56 drug label records with BENZOYL PEROXIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Acne Treatment Cream used for?
Use(s) for the treatment of acne

Who makes Acne Treatment Cream?
CVS Health is the labeler of record for Acne Treatment Cream. 56 FDA label records share the active ingredient BENZOYL PEROXIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Acne Treatment Cream come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Acne Treatment Cream prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BENZOYL PEROXIDE?
Yes. 56 FDA drug label records list BENZOYL PEROXIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Acne Treatment Cream been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.