BENZOYL PEROXIDE suspension

benzoyl peroxide by

Drug Labeling and Warnings

benzoyl peroxide by is a Otc medication manufactured, distributed, or labeled by Padagis Israel Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do not use

if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

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
• avoid contact with hair and 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. (1-800-222-1222)

Directions

• shake well
• Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
• wet area to be cleansed
• apply acne wash and gently massage area for 1-2 minutes
• rinse thoroughly and pat dry
• 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

carbomer homopolymer, citric acid*, edetate disodium, glycerin, imidurea, lauryl methacrylate/glycol dimethacrylate crosspolymer, purified water, sodium C14-16 olefin sulfonate, sodium hydroxide *may contain this ingredient

Questions?

1-800-719-9260

Package/Label Principal Display Panel

Benzoyl Peroxide 10%

Acne Medication Wash

NET WT 8 OZ (227 g)

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE 
benzoyl peroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45802-318
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
IMIDUREA (UNII: M629807ATL)
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45802-318-01	142 g in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2013
2	NDC: 45802-318-34	227 g in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/20/2013

Labeler - Perrigo New York Inc (078846912)