BENZOYL PEROXIDE by Cintex Services, LLC BENZOYL PEROXIDE gel

BENZOYL PEROXIDE by

Drug Labeling and Warnings

BENZOYL PEROXIDE by is a Otc medication manufactured, distributed, or labeled by Cintex Services, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl peroxide 5%

Purpose

Acne treatment

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

Stop use and ask a doctor if  

irritation becomes severe.

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer and rinse thoroughly 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 15°-30°C (59°-86°F).

Inactive ingredients

allantoin, aloe barbadensis leaf extract, benzyl alcohol, carbomer, disodium EDTA, disodium laureth sulfosuccinate, glycerin, panthenol, PEG-8, PPG-14 palmeth-60 hexyl dicarbamate, sodium hyaluronate, triethanolamine, water

Questions?

1-855-899-4237

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24470-909
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PPG-14 PALMETH-60 HEXYL DICARBAMATE (UNII: 376C96Y6AL)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24470-909-60	60 g in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/28/2012

Labeler - Cintex Services, LLC (078304114)