BPO - benzoyl peroxide gel 
Acella Pharmaceuticals, LLC

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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BPO 4% Gel

Active Ingredient

Benzoyl Peroxide 4%

Purpose

Acne Medication

Use treats acne and helps prevent new acne blemishes from forming

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

For External Use only
Do not use if you have very sensitive skin or if you are sensitive to benzoyl peroxide

When using this product

Direction

Inactive Ingredients

aloe barbadebsis leaf juice, benzyl alcohol, ceteareth-20, cetyl alcohol, dimethyl isisirbide, purified water, simethicone and stearyl alcohol.

Tube

BPO  
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42192-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE4 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42192-105-1612 in 1 PACKAGE
11 in 1 CARTON
142500 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D01/01/2009
Labeler - Acella Pharmaceuticals, LLC (825380939)
Registrant - Ei Inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Ei Inc.105803274manufacture(42192-105) , label(42192-105) , pack(42192-105)

Revised: 4/2013
Document Id: 13b45320-6394-47c3-b97d-8a0d2cdd34a9
Set id: 39fb1c4e-4dee-45c2-9422-31cb3bb765d5
Version: 1
Effective Time: 20130404
 
Acella Pharmaceuticals, LLC