Benzoyl Peroxide by Cintex Services, LLC BP Foam 5.3%

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]

BENZOYL PEROXIDE- benzoyl peroxide aerosol, foam 
Cintex Services, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BP Foam 5.3%

Active ingredient

Benzoyl peroxide 5.3%

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.
• do not puncture or incinerate; contents under pressure

Stop use and ask a doctor if irritation becomes severe.

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 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

Inactive ingredients

emulsifying wax, methylparaben, propylparaben, purified water, tetrafluoroethane

Questions?

1-855-899-4237

BENZOYL PEROXIDE 
benzoyl peroxide aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24470-912
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	53 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
1,1,2,2-TETRAFLUOROETHANE (UNII: X2I96B6OVW)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24470-912-60	60 g in 1 CANISTER; Type 0: Not a Combination Product	03/04/2011	01/31/2020
2	NDC: 24470-912-10	100 g in 1 CANISTER; Type 0: Not a Combination Product	03/04/2011	01/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/04/2011	01/31/2020

Labeler - Cintex Services, LLC (078304114)

Revised: 12/2018

Document Id: 7ce9a5c4-5aec-a21f-e053-2991aa0a0171

34390-5

Set id: 760d3717-4cb8-495d-87f7-af58255a8d9f

Version: 2

Effective Time: 20181213

 

Cintex Services, LLC