Adapalene by Wal-Mart Stores Inc / Sun Pharma Canada Inc. ADAPALENE gel

Adapalene by

Drug Labeling and Warnings

Adapalene by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, Sun Pharma Canada Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts
Active ingredient

Adapalene USP, 0.1% (retinoid) 1

1 read consumer information leaflet

Purpose

Acne treatment

Use

For the treatment of acne

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:

use once daily
clean the skin gently and pat dry before applying the product
cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face.
do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.

Children under 12 years of age: ask a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].
protect from freezing

Inactive ingredients

carbomer homopolymer type C, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water, sodium hydroxide.

Questions?

1-888-287-1915

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DISTRIBUTED BY:
Walmart Inc.,
Bentonville, AR 72716

PRODUCT OF CANADA

PRINCIPAL DISPLAY PANEL - 15 g Carton

NDC: 79903-338-05

Adapalene
Gel USP, 0.1%

Carton

INGREDIENTS AND APPEARANCE

ADAPALENE
adapalene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-338
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)	ADAPALENE	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 79903-338-05	1 in 1 CARTON	06/06/2025
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215940	06/06/2025

Labeler - Wal-Mart Stores Inc (051957769)

Name	Address	ID/FEI	Business Operations
Establishment
Sun Pharma Canada Inc.		243339023	manufacture(79903-338)