ADAPALENE GEL- adaplaene gel

Adapalene Gel by

Drug Labeling and Warnings

Adapalene Gel by is a Otc medication manufactured, distributed, or labeled by Acne Free LLC, Glenmark Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

Other information

store at room temperature 68º to 77ºF protect from freezing

INACTIVE INGREDIENT

carbomer homopolymer, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water and sodium hydroxide

Questions or comments

1-800-768-2913

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADAPALENE GEL 
adaplaene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80861-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)	ADAPALENE	0.00036 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)

Product Characteristics
Color	white (clear, transparent)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80861-114-01	1 g in 1 TUBE; Type 0: Not a Combination Product	12/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091314	12/20/2023

Labeler - Acne Free LLC (122237140)

Establishment
Name	Address	ID/FEI	Business Operations
Glenmark Pharmaceuticals Limited		677318665	manufacture(80861-114)