Kaiser Foundation Hospitals Benzoyl Peroxide 10% Drug Facts

kaiser permanente benzoyl peroxide by

Drug Labeling and Warnings

kaiser permanente benzoyl peroxide by is a Otc medication manufactured, distributed, or labeled by Kaiser Foundation Hospitals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KAISER PERMANENTE BENZOYL PEROXIDE- benzoyl peroxide suspension 
Kaiser Foundation Hospitals

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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Kaiser Foundation Hospitals Benzoyl Peroxide 10% Drug Facts

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Uses

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 or comments?

1-800-719-9260

Package/Label Principal Display Panel

Benzoyl Peroxide 10%

Maximum strength

Acne treatment wash

Fragrance free

NET WT 5 OZ (142 g)

KAISER PERMANENTE BENZOYL PEROXIDE 
benzoyl peroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0179-8704
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: 0179-8704-05	142 g in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2007	01/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/08/2007	01/31/2020

Labeler - Kaiser Foundation Hospitals (053052619)

Revised: 11/2018

Document Id: 7b0a69cc-b667-b5d2-e053-2a91aa0ac91d

34390-5

Set id: 5bd81128-0800-4d65-ba75-09cf6d7d5854

Version: 4

Effective Time: 20181119

 

Kaiser Foundation Hospitals