ADAPALENE- adapalene gel 
Topco Associates

----------

Adapalene Gel 0 1 percent 0 5

Active ingredient

Agapalene, USP 0.1% (retinoid)*

*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

Pregnancy/Breastfeeding,

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 become 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 result
  • avoid product contact eyes, lips, and month. If contact occurs immediately flush the area with water.
  • wash hands after use

Stop use and ask a doctor if

  • you become pregnant, or planning to become pregnant while using this product
  • you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
  • irritation become 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 (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and older:

Other information

Inactive ingredients

carbomer homopolymertype C, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water

May contain hydrochloric acid and /or sodium hydroxide to adjust pH.

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

Compare to the active ingredient in DIFFERIN® GEL†

ADAPALENE GEL USP  0.1%

ACNE TREATMENT

OIL & FRAGRANCE FREE

*Read consumer information leaflet before use

*This product is not manufactured or distributed by Galderma Laboratories, L.P. distributor of Differin® Gel.

DISTRIBUTED BY TOPCO

ASSOCIATES LLC

ITASCA, IL 60143

Product Label

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

TOP CARE BEAUTY Acne Treatment

ADAPALENE 
adapalene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-114
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)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLOXAMER 182 (UNII: JX0HIX6OAG)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-114-051 in 1 CARTON11/30/2023
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09096211/30/2023
Labeler - Topco Associates (006935977)

Revised: 3/2024
Document Id: 83d425c7-cc51-4637-8a35-d6a21c1d99b1
Set id: 5693e3c9-00e5-4e62-b44a-47be2dc31811
Version: 3
Effective Time: 20240301
 
Topco Associates