Adapalene by Actavis Pharma, Inc. ADAPALENE GEL, 0.1%

Drug Details [pdf]

ADAPALENE- adapalene gel
Actavis Pharma, Inc.

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ADAPALENE GEL, 0.1%

Drug Facts

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

Purpose

Acne Treatment

Use

For the treatment of acne

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, 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 a 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

Keep out of reach of children.

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

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

Other information

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

Inactive ingredients

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?

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

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)

ADAPALENE
adapalene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0591-0375
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)	ADAPALENE	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLOXAMER 182 (UNII: JX0HIX6OAG)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0591-0375-89	1 in 1 CARTON	11/30/2023	11/30/2023
1		45 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0591-0375-86	1 in 1 CARTON	11/30/2023	11/30/2023
2		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090962	11/30/2023	11/30/2023

Labeler - Actavis Pharma, Inc. (119723554)

Revised: 1/2024

Document Id: c584f1fa-7100-4cac-976d-42bafe1aae05

Set id: 3f08b5ad-7b0d-4abc-88a2-cf1e1e98c81f

Version: 6

Effective Time: 20240103