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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Drug Facts

Active Ingredient: (in each 0.9 gram) : Neomycin Sulfate, 5mg

Uses: First aid to prevent infection in minor cuts, scrapes, burns

Purpose: First Aid Antibiotic

Warnings: For external use only.  Do not use: if you are allergic to any of the ingredients, in the eyes, over large areas of the body.  Ask a doctor before use if you have: large puncture wounds, animal bites, serious burns. 

Stop use and ask a doctor if: you need to use longer than one week, condition persists or gets worse, symptoms persist for more than one week or clear up and occur again within a few days, rash or other allergic reaction develops.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Adults and children over 2 years of age or older: Clean the affected area.  Apply contents of packet to surface of affected area 2 times daily.  Gently rub in. Children under 2 years of age: Ask a doctor.

Inactive Ingredients:Ascorbic Acid, Benzoic Acid, Chlorphenesin, Citric Acid, Glycerin, Glycerol MS S.E., Magnesium Stearate, Methyl Paraben, Phenoxyethanol, Polysorbate 80, SDBS, Trisodium Citrate, Stearic Acid, USP Water, White Petrolatum

Baclezene Carton

BACLEZENE 
neomycin sulfate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52599-282
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 0.9 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PETROLATUM (UNII: 4T6H12BN9U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52599-282-8320 in 1 CARTON06/19/2014
1NDC:52599-282-820.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00506/19/201406/19/2014
Labeler - Curazene, LLC (005078008)
Registrant - Curazene, LLC (005078008)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004pack(52599-282)

Revised: 1/2023
 
Curazene, LLC