NEUTROGENA ON-THE-SPOT ACNE TREATMENT VANISHING FORMULA- benzoyl peroxide cream

Neutrogena On-the-Spot Acne Treatment by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

Active Ingredients

Benzoyl Peroxide (2.5%)

Purpose

Acne Medication

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.

Do not use if you

• Have very sensitive skin.
• Are sensitive to benzoyl peroxide.

When using this product

• Avoid unnecessary sun exposure and use a sunscreen.
• Avoid contact with the eyes, lips and mouth.
• Avoid contact with hair or dyed fabrics, 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.

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?

Call toll-free 800-582-4048 or 215-273-8755 (collect). www.neutrogena.com

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

PRINCIPAL DISPLAY PANEL - 21g Tube Carton

VANISHING CREAM FORMULA

On-the-Spot®
Acne Treatment

fights acne-causing bacteria
while gentle on skin

benzoyl peroxide acne medication
CLINICALLY PROVEN POWER
Tough on Acne,
Easy on Your Skin

Neutrogena®

DERMATOLOGIST RECOMMENDED

NET WT .75 OZ (21g)

INGREDIENTS AND APPEARANCE

NEUTROGENA ON-THE-SPOT ACNE TREATMENT   VANISHING FORMULA
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0164
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: 69968-0164-1	1 in 1 CARTON	02/01/2016
1		21 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 FINAL	part333D	02/01/2016

Labeler - Johnson & Johnson Consumer Inc. (002347102)