Adapalene Gel

Adapalene Gel is an FDA-registered drug product whose active ingredient is ADAPLAENE. It is labelled by Acne Free LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 80861-114, application ANDA091314, label effective 20260731. 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 ADAPLAENE 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 for the treatment of acne

Directions • use once daily • clean the skin gently and pat dry before applying the product • cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face. Adults and children 12 years of age and older: do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation Children under 12 years of age: ask a doctor

Warnings For external use only Do not use on damaged skin (cuts, abrasions, eczema, sunburn) if you are allergic to adapalene or any of the ingredients in this product If pregnant or breast-feeding If pregnant or breast-feeding, ask a doctor before use When using this product limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors do not wax to remove hair in areas where the product has been applied during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe irritation (redness, itching, dryness, burning) is more likely to occur: • in the first few weeks of use • if using more than one topical acne medication at a time • but irritation usually lessens with continued use of this product it may take up to 3 months of once daily use to see results avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water. wash hands after use Stop use and ask a doctor if you become pregnant, or are planning to become pregnant, while using the product you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath) irritation becomes severe you see no improvement after 3 months of once daily use Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

What is Adapalene Gel used for?
USE for the treatment of acne

Who makes Adapalene Gel?
Acne Free LLC is the labeler of record for Adapalene Gel.

What form does Adapalene Gel 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 Adapalene Gel 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.

Has Adapalene Gel been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.