Your browser does not support JavaScript! GNP ACNE TREATMENT (BENZOYL PEROXIDE) CREAM [AMERISOURCE BERGEN]
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RxNorm Names

GNP ACNE TREATMENT (benzoyl peroxide) cream
[Amerisource Bergen]


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                                                                       Purpose

Benzoyl Peroxide 10%.................................................Acne Medication

Uses

  • for the treatment and prevention of acne pimples

Warnings

  • for external use only

Do not use if you have sensitive skin or are sensitive to benzoyl peroxide

When using this product

  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
  • with other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or concentration may aggravate skin irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if skin irritation becomes severe

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • cleanse the skin thoroughly before applying medication
  • cover the entire affected area with a thin layer one to three times a day
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as direction by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • use to prevent new pimples from forming

Other information

  • keep tightly closed
  • keep away from heat

Inactive ingredients liquid paraffin, white petrolatum, cetanol, propylene glycol, stearyl alcohol, polyoxyehylencetylether, sorbitanmonostearate, polysorbate 60, methylparaben, butyl paraben, purified water

Distributed by

Amerisource Bergen

1300 Morris Drive

Chesterbrook, PA 19087

Made in Korea

image of carton label
GNP ACNE TREATMENT  
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:46122-044
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
PROPYLENE GLYCOL 
STEARYL ALCOHOL 
POLYSORBATE 60 
METHYLPARABEN 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-044-031 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/30/2013
Labeler - Amerisource Bergen (007914906)

Revised: 6/2013
 
Amerisource Bergen

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