ADAPALENE GEL- adaplaene gel 
Acne Free LLC

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Adapalene Gel 15g

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

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

Questions or comments

1-800-768-2913

Adapalene Gel

ADAPALENE GEL 
adaplaene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80861-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE0.00036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
Product Characteristics
Colorwhite (clear, transparent) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80861-114-011 g in 1 TUBE; Type 0: Not a Combination Product12/20/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09131412/20/2023
Labeler - Acne Free LLC (122237140)
Establishment
NameAddressID/FEIBusiness Operations
Glenmark Pharmaceuticals Limited677318665manufacture(80861-114)

Revised: 1/2024
Document Id: 0ce4684a-4734-e669-e063-6394a90a58c1
Set id: 0ce4684a-4733-e669-e063-6394a90a58c1
Version: 1
Effective Time: 20240108
 
Acne Free LLC