ACNE MEDICATION 5- 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 5% DRUG FACTS

Active ingredient

Active Ingredient

5% benzoyl peroxide

Uses

Uses

Warnings

Warnings

For external use only

Do not use if you

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 number and expiration date: See box or bottle

When using this product

When using this product

Inactive ingredients

Inactive Ingredients

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

Distributed by:

RUGBY LABORATORIES
LIVONIA, MI 48150 USA

Principal Display Panel

PRINCIPAL DISPLAY PANEL 8OZ BOTTLE LABEL

NDC 0536-0810-95
BENZOYL PEROXIDE 5%
Clear Up Acne Pimples

FOR TOPICAL USE

Net Weight 1 fl oz

Acne Medication 5% Lotion







 


Purpose

 Acne treatment

Questions?

 Call 1-(800) 645-2158

ACNE MEDICATION 5 
benzoyl peroxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-0810
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 50 mg  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
STEARETH-30 (UNII: 5776GCL1DG)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
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:0536-0810-95 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: 57391419-7fdf-49d8-bac7-0ce353f0a835
Set id: 797c64fc-7f3d-4c95-9bb5-5595dca8717b
Version: 2
Effective Time: 20130115
 
Rugby Laboratories