ADAPALENE- adapalene gel 
The Kroger Co.

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Adapalene Gel USP 0 1 percent ENE

Active ingredient

Adapalene, 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

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 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 results
  • avoid product contact 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 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 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 homopolymer type 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 1-800-632-6900

Principal Display Panel

Compare to the Active Ingredient in Differin® Gel

ADAPALENE GEL USP 0.1%

acne treatment

ONCE DAILY TOPICAL RETINOID*

Oil & fragrance free

dermatologist developed & tested

previously available only by prescription

*READ CONSUMER INFORMATION LEAFLET BEFORE USE

NET WT OZ (g)

*READ CARTON AND ENCLOSED CONSUMER INFORMATION LEAFLET BEFORE USING THIS PRODUCT.

KEEP THIS CARTON AND CONSUMER INFORMATION LEAFLET. THEY CONTAIN IMPORTANT INFORMATION.

DIFFERIN® GEL IS A REGISTERED TRADEMARK OF GALDERMA LABORATORIES, L.P., DALLAS, TX 75201.

GALDERMA LABORATORIES, L.P. IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

Product Label

Acne Treatment

Adapalene Gel USP 0.1%

ADAPALENE 
adapalene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-725
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)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-725-051 in 1 CARTON03/15/2024
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09096203/15/2024
Labeler - The Kroger Co. (006999528)

Revised: 3/2024
Document Id: d436cc7a-0eae-485e-9817-9ff208b0dbfe
Set id: 1238c72c-1c51-46e4-b15c-61093b03608e
Version: 5
Effective Time: 20240314
 
The Kroger Co.