GNP ACNE TREATMENT  - benzoyl peroxide cream 
Amerisource Bergen

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                                                                       Purpose

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

Uses

Warnings

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

When using this product

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

Other information

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 Type HUMAN OTC DRUG Item Code (Source) NDC:46122-044
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:46122-044-03 1 in 1 CARTON
1 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 06/30/2013
Labeler - Amerisource Bergen (007914906)

Revised: 6/2013
Document Id: f0abc596-7093-4a63-b3e5-d507c7085ba1
Set id: 63f2ac3c-178c-4678-a4e0-d7f0c65de35c
Version: 3
Effective Time: 20130630
 
Amerisource Bergen