BPO by Acella Pharmaceuticals, LLC / Harmony Labs, Inc. BPO 8% Gel

BPO by

Drug Labeling and Warnings

BPO by is a Prescription medication manufactured, distributed, or labeled by Acella Pharmaceuticals, LLC, Harmony Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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BPO 8% Gel

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

Tube
Unit Carton
BPO  
benzoyl peroxide gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 42192-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide8 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42192-106-151 in 1 PACKAGE02/09/200802/29/2020
142500 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/09/200802/29/2020
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: 9/2018
Document Id: 9ef3797d-4de6-4aa3-bffa-a2f78e40290d
Set id: 3521b554-2f98-499a-89f4-49522be1ffc9
Version: 6
Effective Time: 20180927
 
Acella Pharmaceuticals, LLC