NEUTROGENA STUBBORN ACNE AM TREATMENT- benzoyl peroxide gel

Neutrogena Stubborn Acne AM Treatment by

Drug Labeling and Warnings

Neutrogena Stubborn Acne AM Treatment by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzoyl Peroxide (2.5%)

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only.

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips and mouth. If contact occurs, flush thoroughly with water
• avoid contact with hair or dyed products, which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide.

Stop use and ask a doctor if

• Irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

• Store at 20°C to 25°C (68°F - 77°F)

Inactive ingredients

Water, Carbomer Homopolymer type B, Ethylhexylglycerin, Sodium Hydroxide, Chlorphenesin, Disodium EDTA, Laureth-4, Hydroxypropyl Methylcellulose

Questions?

800-582-4048; Outside US, dial collect 215-273-8755 or visit www.neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

New
Neutrogena ®
DERMATOLOGIST RECOMMENDED BRAND
STUBBORN
ACNE
AM TREATMENT
Benzoyl Peroxide
Acne treatment

works all day to help
eliminate stubborn acne

2.5% Micronized BPO

NET WT. 2.0 OZ
(56 g)

INGREDIENTS AND APPEARANCE

NEUTROGENA STUBBORN ACNE AM TREATMENT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0653
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURETH-4 (UNII: 6HQ855798J)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0653-2	1 in 1 CARTON	08/03/2020
1		56 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69968-0653-1	12 in 1 PACKAGE	08/03/2020
2		9 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
OTC Monograph Drug	M006	08/03/2020

Labeler - Kenvue Brands LLC (118772437)