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Benzoyl Peroxide by Harris Pharmaceutical, Inc.

Medically reviewed on December 15, 2017

Dosage form: liquid
Ingredients: Benzoyl Peroxide 60mg in 1mL
Labeler: Harris Pharmaceutical, Inc.
NDC Code: 67405-835

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.

BENZOYL PEROXIDE TOPICAL CLEANSER 6%

DRUG FACTS

Active Ingredient

6% benzoyl peroxide USP

Purpose

Acne medication

Use
  • For the treatment of acne

Warnings:

For external use only.

  • Avoid contact with eyes, eyelids, lips and mucous membranes.

Do not use if you
  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product
  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid contact with eyes, lips, and mouth.
  • Avoid contact with hair or 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.
  • 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.

  • 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.

Directions

SHAKE WELL.

  • Clean the skin thoroughly before applying this product.
  • One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, 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.
  • Follow directions in the sunscreen labeling.
  • If irritation or sensitivity develops stop use of both products and ask a doctor.

Other information

Store at controlled room temperature, 15° - 25°C (59° - 77°F)

Inactive Ingredients

Carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.

Manufactured for:
Harris Pharmaceutical, Inc.,
Fort Myers, Florida 33908
Manufactured by:
Groupe Parima
Montreal, QC
H4S 1X6 CANADA Rev 06/11

PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label

NDC 67405-835-06

BENZOYL
PEROXIDE
TOPICAL
CLEANSER
6%

FOR TOPICAL USE

Net Weight 6 oz
(170.3 g)

HARRIS

BENZOYL PEROXIDE 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67405-835
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
cetyl alcohol 
disodium oleamido MEA-sulfosuccinate 
edetate disodium 
glycerin 
laureth-12 
magnesium aluminum silicate 
propylene glycol 
water 
sodium coco-sulfate 
sodium lauroamphoacetate 
xanthan gum 
Product Characteristics
ColorWHITE (viscous) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67405-835-06178 mL in 1 BOTTLE
2NDC:67405-835-12355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D11/18/2011
Labeler - Harris Pharmaceutical, Inc. (617204370)
Establishment
NameAddressID/FEIOperations
Groupe Parima Montreal252437850MANUFACTURE(67405-835)

 
Harris Pharmaceutical, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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