ADAPALENE- adapalene gel 
AMERISOURCE BERGEN

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Adapalene

Drug Facts

Active ingredient

Adapalene USP, 0.1% (retinoid) 1


1
read consumer information leaflet

Purpose

Acne treatment

Use

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 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:

Children under 12 years of age:ask a doctor

Other information

Inactive ingredients

carbomer homopolymer type C, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water, sodium hydroxide.

Questions?

1-866-923-4914

Distributed By AmerisourceBergen
1 West First Ave., Conshohocken
PA 19428

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

NDC 46122-768-36

Compare to the
Differin ®Gel
active ingredient

GOOD
NEIGHBOR
PHARMACY ®

PARABEN FREE

Adapalene
Gel USP, 0.1%
Acne Treatment

* Read consumer information
leaflet before use

NET WT
0.5 oz (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
ADAPALENE 
adapalene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-768
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLOXAMER 182 (UNII: JX0HIX6OAG)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-768-361 in 1 CARTON02/26/2024
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21594002/26/2024
Labeler - AMERISOURCE BERGEN (007914906)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295manufacture(46122-768)

Revised: 3/2024
Document Id: 1322b815-9730-b22a-e063-6294a90af09d
Set id: 8d6e2e28-a11a-4443-a43b-098a55622e24
Version: 1
Effective Time: 20240308
 
AMERISOURCE BERGEN