ACNE MEDICATION 10- benzoyl peroxide lotion 
Rugby Laboratories

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

Active Ingredient

10% benzoyl peroxide

Uses

Uses

Warnings

Warnings

For external use only

Do not use

Do not use

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

Stop use and ask a doctor

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

Keep out of reach of children

Keep out of reach of children.

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

Directions

Directions

Other information

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)

Lot No. & Exp. Date: See box or bottle

Purpose

Purpose

Acne Treatment

When using this product

When using this product

Inactive ingredients

Inactive Ingredients

purified water, brij 30, carbomer, diisopropanolamine, disodium edetate

Distributed by:
Rugby Laboratories
Livonia, MI 48150 USA

Principal display panel



NDC 0536-0815-95

BENZOYL PEROXIDE 10%

FOR TOPICAL USE

Acne Medication Lotion 10%



Questions?

 Call 1-(800) 645-2158

ACNE MEDICATION 10 
benzoyl peroxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-0815
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
STEARETH-30 (UNII: 5776GCL1DG)  
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-0815-95 30 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 10/29/2012
Labeler - Rugby Laboratories (191427277)

Revised: 1/2013
Document Id: d4e80132-a7d9-453c-813b-fbcf883f198e
Set id: e4680a46-a8e3-40e5-a491-f45de77382a9
Version: 1
Effective Time: 20130115
 
Rugby Laboratories