NEUTROGENA ADAPALENE 0.1% ACNE TREATMENT- adapalene gel

Neutrogena Adapalene 0.1% Acne Treatment by

Drug Labeling and Warnings

Neutrogena Adapalene 0.1% Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Adapalene, USP 0.1% (retinoid)*

*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 the 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 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 (1-800-222-1222) right away.

Directions

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

▪ store at room temperature 68° to 77°F

▪ protect from freezing

Inactive ingredients

carbomer homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water

May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

Call 800-582-4048; Outside US, dial collect

215-273-8755 or visit www.neutrogena.com

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Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

NEW

Adapalene

Gel 0.1%

Acne Treatment

Previously available only

By prescription

Dermatologist developed

& tested

Once Daily Topical

Retinoid*

Oil Free

Fragrance Free

*Read consumer information

leaflet before use

NET WT 1.6 OZ (45 g)

INGREDIENTS AND APPEARANCE

NEUTROGENA ADAPALENE 0.1% ACNE TREATMENT 
adapalene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0826
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLOXAMER 182 (UNII: JX0HIX6OAG)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0826-1	1 in 1 CARTON	12/04/2023
1		45 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090962	12/04/2023

Labeler - Kenvue Brands LLC (118772437)