Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

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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Drug Facts

Active ingredient

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

treats acne

dries up acne pimples

helps prevent new acne pimples

Warnings

For external use only

Do not use:

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

Directions

shake well

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 gradual increase to two three 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 using this product.

if irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Sensitivity Test for New Users: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occrs, follow the directions stated above

Inactive Ingredients

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

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 No. & Exp. Date: See box or bottle

Distributed by:

Rugby Laboratories

Livonia, MI 48150 USA

Questions?

Call 1-(800) 645-2158

Principal Display Panel

NDC: 0536-0815-95

BENZOYL PEROXIDE 10%

FOR TOPICAL USE

carton label
ACNE MEDICATION 10 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-0815
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-0815-9530 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/29/201204/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/29/201204/30/2018
Labeler - Rugby Laboratories (079246066)

Revised: 9/2019
 

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