BACLEZENE- neomycin sulfate cream 
Curazene, 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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Baclezene

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BACLEZENE 
neomycin sulfate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52599-282
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN.005 g  in .9 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM.0374 g  in .9 g
POLYSORBATE 80.0329 g  in .9 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52599-282-8320 in 1 PACKAGE
1.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/16/2014
Labeler - Curazene, LLC (005078008)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corp.085752004api manufacture(52599-282), manufacture(52599-282)

Revised: 6/2014
Document Id: f7cd5a9f-1ed0-43a2-b1a1-18098b5d7b08
Set id: a82852eb-18e9-431a-b3d6-80abfdbf8662
Version: 1
Effective Time: 20140601
 
Curazene, LLC