BPO - benzoyl peroxide gel 
Acella Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Tube
Unit Carton

Manufactured for: Acelia Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30009
1 -800-541 -4802
Rev. 12/09

BPO  
benzoyl peroxide gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:42192-106
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide8 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
DIMETHYL ISOSORBIDE 
CETYL ALCOHOL 
STEARYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
BENZYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:42192-106-151 in 1 CASE
11 in 1 CARTON
142500 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/200901/01/2013
Labeler - Acella Pharmaceuticals, LLC (825380939)
Registrant - Harmony Labs, Inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Harmony Labs, Inc.105803274manufacture(42192-106), label(42192-106), pack(42192-106), relabel(42192-106), repack(42192-106)

Revised: 03/2013
Document Id: 6a214130-8f18-492e-98e3-a64f47fa9b54
Set id: 3521b554-2f98-499a-89f4-49522be1ffc9
Version: 4
Effective Time: 20130328
 
Acella Pharmaceuticals, LLC