ADAPALENE- adapalene gel 
Safeway, Inc.

----------

Adapalene Gel USP 0 1 percent

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 homopolymer, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water, sodium hydroxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Differin® Gel active ingredient

ACNE TREATMENT

ADAPALENE GEL USP, 0.1%

Oil free | Fragrance free

Dermatologist developed and tested

*Read consumer information leaflet before use

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

Product Label

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

SIGNATURE CARE Acne Treatment

ADAPALENE 
adapalene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-708
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:21130-708-051 in 1 CARTON08/30/2019
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09131408/30/2019
Labeler - Safeway, Inc. (009137209)

Revised: 6/2020
Document Id: c85fd81f-1b54-4235-9f72-982b4bf004f6
Set id: e41523dc-61e2-45b5-b2c5-4e87931fd5fc
Version: 2
Effective Time: 20200617
 
Safeway, Inc.