Kaiser Foundation Hospitals Benzoyl Peroxide 5% 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 gel 
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 5% Drug Facts

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 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

• 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.
• 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.

Other information

• store at 20°-25°C (68°-77°F)

Inactive ingredients

carbomer homopolymer, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, sodium hydroxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Benzoyl Peroxide 5%

Aqueous base, acne treatment gel

NET WT 2 OZ (56.7 g)

KAISER PERMANENTE BENZOYL PEROXIDE 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0179-8702
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLOXAMER 182 (UNII: JX0HIX6OAG)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0179-8702-60	1 in 1 CARTON	06/08/2007	12/31/2019
1		56.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/08/2007	12/31/2019

Labeler - Kaiser Foundation Hospitals (053052619)

Revised: 11/2018

Document Id: 7b09c11c-9cc0-0ec9-e053-2991aa0a39b3

34390-5

Set id: 55bbf574-065b-4cf4-8c8f-06f1948ea949

Version: 3

Effective Time: 20181119

 

Kaiser Foundation Hospitals