Your browser does not support JavaScript! ACNE MEDICATION 5 (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

ACNE MEDICATION 5 (benzoyl peroxide) lotion
[Rugby Laboratories]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

Active Ingredient

5% benzoyl peroxide

Uses

Uses

  • treats acne
  • dries up acne pimples
  • helps prevent new acne pimples

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

  • 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 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

  • 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
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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-0810
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE50 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
STEARETH-30 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
DIISOPROPANOLAMINE 
EDETATE DISODIUM 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-0810-9530 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/29/2012
Labeler - Rugby Laboratories (191427277)

Revised: 1/2013
 
Rugby Laboratories

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services