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

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

  • 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.

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

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Benzoyl Peroxide 5%

Aqueous base, acne treatment gel

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Benzoyl Peroxide 5% Carton Image 1

Benzoyl Peroxide 5% Carton Image 1

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KAISER PERMANENTE BENZOYL PEROXIDE 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0179-8702
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE 
DISODIUM LAURYL SULFOSUCCINATE 
EDETATE DISODIUM 
GLYCERIN 
METHYLPARABEN 
POLOXAMER 182 
WATER 
SILICON DIOXIDE 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0179-8702-601 in 1 CARTON
156.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/08/2007
Labeler - Kaiser Foundation Hospitals (053052619)

Revised: 2/2012
 
Kaiser Foundation Hospitals