ADAPALENE- adapalene gel 
Taro Pharmaceuticals U.S.A., Inc.

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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, methylparaben, poloxamer 182, propylene glycol, purified water, sodium hydroxide.

Questions?

1-866-923-4914

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.

Hawthorne, NY 10532

Adapalene Gel USP, 0.1%
Acne Treatment

Frequently Asked Questions

What is adapalene gel and what is it used for?

What should I know before using the product?

How often do I apply the product?

How do I apply the product?

How long will it take for adapalene gel to work?

What do I do if I need to be in the sun?

Can I use a moisturizer if my skin is dry?

When is my skin most likely to become irritated? And what do I do?

What do I do if my skin becomes severely irritated?

Can I remove unwanted facial hair by waxing while using this product?

What ingredients are used in adapalene gel?

How should I store this product?

Other Questions? Where can I get more information?
Phone:
1-866-923-4914

Mfd. by: Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1
Made in Canada
Issued: November 2021
5225941 47

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Compare to the
active ingredient in
Differin® Gel

NDC 51672-2143-1

Adapalene

Gel USP, 0.1%
Acne Treatment

Previously available only by prescription
FDA approved
Dermatologist developed
Once Daily Topical Retinoid*

* 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:51672-2143
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:51672-2143-11 in 1 CARTON01/14/2022
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51672-2143-61 in 1 CARTON01/14/2022
245 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21594001/14/2022
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2143)

Revised: 1/2022
Document Id: 740cf78a-9728-4245-9ca2-448d2c9a997d
Set id: a9ca1f7a-71c3-4814-9366-e7e5760bf32c
Version: 3
Effective Time: 20220113
 
Taro Pharmaceuticals U.S.A., Inc.