ADAPALENE- adapalene gel 
RITE AID

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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: RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

NDC 11822-0062-1

ADAPALENE
GEL USP, 0.1%

ACNE TREATMENT

PREVIOUSLY AVAILABLE
ONLY BY PRESCRIPTION
DERMATOLOGIST DEVELOPED

FDA APPROVED

ONCE DAILY TOPICAL RETINOID*

RYSHI

COMPARE TO THE ACTIVE
INGREDIENT IN DIFFERIN ®GEL

* 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:11822-0062
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:11822-0062-11 in 1 CARTON04/15/2024
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21594004/15/2024
Labeler - RITE AID (014578892)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295manufacture(11822-0062)

Revised: 4/2024
Document Id: 16b4acc0-88c0-163e-e063-6394a90acddd
Set id: 0c96c096-73f8-5bc2-e063-6294a90a235f
Version: 3
Effective Time: 20240422
 
RITE AID