BENZOYL PEROXIDE- benzoyl peroxide liquid 
Harris Pharmaceutical, Inc.

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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BENZOYL PEROXIDE TOPICAL WASH 10%

DRUG FACTS

Active Ingredient

10% benzoyl peroxide USP

Purpose

Acne medication

Use

Warnings

For external use only.

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.

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 - 148 g Bottle Label

NDC 67405-830-05

BENZOYL
PEROXIDE
TOPICAL
WASH 10%

FOR TOPICAL USE

Net Weight 5 oz
(148 g)

HARRIS

Principal Display Panel - 148 g Bottle Label

BENZOYL PEROXIDE 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67405-830
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
cetyl alcohol (UNII: 936JST6JCN)  
DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY)  
edetate disodium (UNII: 7FLD91C86K)  
glycerin (UNII: PDC6A3C0OX)  
laureth-12 (UNII: OAH19558U1)  
magnesium aluminum silicate (UNII: 6M3P64V0NC)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium coco-sulfate (UNII: 3599J29ANH)  
sodium lauroamphoacetate (UNII: SLK428451L)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (viscous) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67405-830-05148 mL in 1 BOTTLE; Type 0: Not a Combination Product11/18/2011
2NDC:67405-830-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/18/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D11/18/2011
Labeler - Harris Pharmaceutical, Inc. (617204370)
Establishment
NameAddressID/FEIBusiness Operations
Groupe Parima Montreal252437850MANUFACTURE(67405-830)

Revised: 12/2019
Document Id: e6717de6-d59f-4d01-8846-c0fa35e1f43b
Set id: 98a495f6-367a-4acc-865e-e15c2e96d58b
Version: 2
Effective Time: 20191226
 
Harris Pharmaceutical, Inc.