BENZOYL PEROXIDE- benzoyl peroxide lotion 
TriMarc Labs

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 5% DRUG FACTS

Active Ingredient

5% benzoyl peroxide

Use

For the treatment of acne.

Warnings

For external use only

Do not use

if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Stop use and ask a doctor if irritation becomes severe and continues.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

  • Shake well
  • wet face
  • apply to hands, add water, work into a lather, and massage gently onto face.
  • rinse thoroughly and pat dry
  • use 2 to 3 times daily 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 use sunscreen. After washing and drying face, follow directions in the sunscreen labeling
  • if irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Other Information

to prevent bleaching, avoid contact with hair or dyed fabric and clothing

KEEP TIGHTLY CLOSE

store at room temperature 15°-30°C (59°-86°F)

Purpose

Acne Treatment

When using this product

  • avoid unnecessary sun exposure and use a sunscreen
  • using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin.  If this occurs, only one drug should be used unless directed by a doctor.
  • irritation may develop, such as redness, burning, itching,peeling, or possibly swelling
  • more frequent use or higher concentrations may aggravate such irritation
  • mild irritation may be reduced by using the product less frequently or in lower concentration
  • keep away from eyes, lips, mouth
  • IT MAY BLEACH HAIR OR DYED FABRICS

Inactive Ingredients

purified water, ammonium lauryl sulfate, disodium cocoamphodiacetate, sodium chloride, carbomer, glycerin, propylene glycol, DMDM hydantoin, sodium hydroxide, methylparaben, and propylparaben.

Manufactured for:

TriMarc Laboratories

Oklahoma City, OK 73127

A Division of PD-Rx Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL 8OZ BOTTLE LABEL

NDC 68752-034-08

BENZOYL PEROXIDE

TOPICAL WASH

5%

FOR TOPICAL USE

Net Weight 8oz

TRIMARC

68752034 Label

Trimarc Label

BENZOYL PEROXIDE 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68752-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68752-034-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/200410/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/16/200410/31/2017
Labeler - TriMarc Labs (156893695)
Registrant - TriMarc Labs (156893695)
Establishment
NameAddressID/FEIBusiness Operations
TriMarc Labs156893695manufacture(68752-034)

Revised: 10/2017
 
TriMarc Labs