ADAPALENE GEL, 0.1%

Manufacturer
Actavis Pharma, Inc.
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:17:26

Label at a glance#

ProductAdapalene
Active ingredientADAPALENE
Label structure11 sections

Dosage and administration

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 store at room temperature...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Adapalene, USP 0.1%
 (retinoid)*
*read consumer information leaflet

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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, ask a doctor before use.

When using this product

OTC - WHEN USING SECTION

  • 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 a ask doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DirectionsAdults and children 12 years of age and older:

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 68°-77°F
  • protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water
May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

OTC - QUESTIONS SECTION

1-888-838-2872 between 9 am and 5 pm ET, Monday – Friday.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0591-0375-86

Adapalene
Gel USP 
0.1%
Acne Treatment

Compare to the active ingredient in Differin® Gel †

  • Previously available only by prescription
  • Once Daily Topical Retinoid*
  • Oil Free
  • Fragrance Free

*Read consumer information leaflet before use

NET WT 0.5 OZ (15g)

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0591-03750591-0375-89, 0591-0375-86

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c584f1fa-7100-4cac-976d-42bafe1aae053f08b5ad-7b0d-4abc-88a2-cf1e1e98c81f2024-01-03WarningsExact identifier
spl set id: 3f08b5ad-7b0d-4abc-88a2-cf1e1e98c81f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.