NEUTROGENA ACNE CONTROL- benzoyl peroxide lotion

Neutrogena Acne Control by

Drug Labeling and Warnings

Neutrogena Acne Control 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 ingredient

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.

Inactive ingredients

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

Questions?

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

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Dist. by Neutrogena Corp., L.A., CA 90045

PRINCIPAL DISPLAY PANEL - 40 mL Tube Label

Neutrogena®

ACNE CONTROL
LOTION
benzoyl peroxide acne medication

INGREDIENTS AND APPEARANCE

NEUTROGENA ACNE CONTROL 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-975
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 mL

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 Anhydrous (UNII: 8NLQ36F6MM)
Laureth-4 (UNII: 6HQ855798J)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-975-01	40 mL in 1 TUBE; Type 0: Not a Combination Product	03/14/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	03/14/2014

Labeler - Johnson & Johnson Consumer Inc. (002347102)