SkinActive ingredient
Adapalene
Topical retinoid1 FDA label read
Adapalene is the retinoid sold from the pharmacy shelf rather than behind the counter. Differin gel 0.1 percent carries a Drug Facts label, the format used for medicines sold without a prescription, rather than the prescribing information a clinician reads. That difference in document is the difference in how the product is sold.
Highlights of the labels
- Differin gel
- Acnecovers skin
- Supply
- Over the counter
- Generic
- 19 approved applications
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| Differin gelGalderma Laboratories, L.P. | What its label approvesAcneCovers skin | SupplyOver the counter | Label version7 December 2022 |
How it works
Adapalene is a retinoid, chemically distinct from tretinoin but acting on the same family of receptors. The over-the-counter Drug Facts label does not describe a mechanism: it states the purpose of the product, which is acne treatment.
What this product is for
The approved uses, as worded in the label.
- acne treatment
- For the treatment of acne
Drug Facts
The presentations and strengths listed in the label.
Active ingredient Adapalene 0.1% (retinoid)* *read consumer information leaflet
Directions Adults and children 12 years of age and older:
What the label states about administration. It is not a dosing instruction for any individual.
- 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.
- 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.
Stop use and ask doctor if
The adverse reactions the label reports as most common.
- 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
Warnings
The warnings and precautions section of the label.
- 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
Do not use
Situations in which the label states the medication must not be used.
- on damaged skin (cuts, abrasions, eczema, sunburn)
- if you are allergic to adapalene or any of the ingredients in this product.
Generic or brand
Generic adapalene gel is approved and sold both over the counter and by prescription, including at a higher 0.3 percent strength that remains prescription only.
The FDA label database lists 19 approved generic applications for this ingredient.
What affects the cost
Being on the shelf rather than behind the counter is the main thing that separates adapalene from tretinoin in cost and access. This site does not link to sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand | Generic |
|---|---|---|
| per gram | Brand$11.27 (range $11.27 to $11.27, 19 listings) | Generic$0.519 (range $0.282 to $2.64, 750 listings) |
Median of 769 listings. Effective dates 2025-05-21 to 2026-07-22, file dated 2026-07-29.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Is adapalene a retinoid, like tretinoin?
- Yes. The Drug Facts label lists the active ingredient as adapalene 0.1 percent and marks it as a retinoid. It is a different molecule from tretinoin with its own approval and its own label.
- How does the label say to use it?
- Once daily, on clean dry skin, covering the entire affected area with a thin layer. The label states that using it more than once a day will not give faster or better results and may worsen irritation.
Other medications under skin
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Differin gel
Galderma Laboratories, L.P.. Label version 10, effective 7 December 2022.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 23 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.