Adapalene
164f52fa-3050-3eea-e063-6394a90a6f70
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Acne treatment
Medication Information
Purpose
Acne treatment
Description
Drug Facts
Use
- For the treatment of acne
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 53414-9
If pregnant or breast-feeding, ask a doctor before use.
Warnings
For external use only
Directions
Adults and children 12 years of age and older:
- 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.
Children under 12 years of age: ask a doctor
Do Not Use
- on damaged skin (cuts, abrasions, eczema, sunburn)
- if you are allergic to adapalene or any of the ingredients in this product.
Questions?
1-800-910-6874
Active Ingredient
Adapalene USP, 0.1% (retinoid)
Other Information
- TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
- store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- protect from freezing
Inactive Ingredients
carbomer homopolymer type C, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water, sodium hydroxide.
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 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
Principal Display Panel 15 G Tube Carton
Adapalene
Gel USP,
0.1%
Acne Treatment
- Previously available by
prescription only - Once daily topical retinoid*
- FDA approved
Dermatologist
Tested
up&up ™
*Read consumer information
leaflet before use
NET WT 0.5 OZ (15 g)
Structured Label Content
Use
- For the treatment of acne
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a doctor before use.
Purpose
Acne treatment
Warnings
For external use only
Directions
Adults and children 12 years of age and older:
- 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.
Children under 12 years of age: ask a doctor
Do Not Use (Do not use)
- on damaged skin (cuts, abrasions, eczema, sunburn)
- if you are allergic to adapalene or any of the ingredients in this product.
Questions?
1-800-910-6874
Active Ingredient (Active ingredient)
Adapalene USP, 0.1% (retinoid)
Other Information (Other information)
- TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
- store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- protect from freezing
Inactive Ingredients (Inactive ingredients)
carbomer homopolymer type C, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water, sodium hydroxide.
When Using This Product (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 Doctor If (Stop use and ask 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
Principal Display Panel 15 G Tube Carton (PRINCIPAL DISPLAY PANEL - 15 g Tube Carton)
Adapalene
Gel USP,
0.1%
Acne Treatment
- Previously available by
prescription only - Once daily topical retinoid*
- FDA approved
Dermatologist
Tested
up&up ™
*Read consumer information
leaflet before use
NET WT 0.5 OZ (15 g)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:59.185271 · Updated: 2026-03-14T23:10:07.372921