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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Drug Facts

Active ingredient

5% benzoyl peroxide

Purpose

Acne treatment

Keep Out of Reach of Children

Keep out of reach of children.

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

Uses

Uses

treats acne
dries up acne pimples
helps prevent new acne pimples

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

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

Directions

Directions

shake well before use
clean the skin thoroughly before applying this product
cover entire affected area with a thin layer one to three times daily
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 use sunscreen after using this product. If irritation or sensitivity develops, discontinue use of both products and consult a doctor
Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above

Other Safety 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

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

Inactive Ingredients

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

Distributed by:

RUGBY LABORATORIES

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Questions

Call 1-(800) 645-2158

Package/Label Principal Display Panel

Acne Medication 5

5%

1 fl oz (30 mL)

carton label
ACNE MEDICATION 5 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-0810
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
STEARETH-30 (UNII: 5776GCL1DG)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-0810-951 in 1 CARTON10/29/201207/31/2018
130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/29/201207/31/2018
Labeler - Rugby Laboratories (079246066)

Revised: 12/2019
 
Rugby Laboratories