Your browser does not support JavaScript! ACNE MEDICATION 10 (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES]
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RxNorm Names

ACNE MEDICATION 10 (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

10% benzoyl peroxide

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 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
  • 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

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

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • 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.
  • skin irritation may develop, such as redness, burning, itching,peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
  • 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
  • IT MAY BLEACH HAIR OR DYED FABRICS

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-0815
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE100 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
STEARETH-30 
DIISOPROPANOLAMINE 
EDETATE DISODIUM 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-0815-9530 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

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