BACLEZENE (NEOMYCIN SULFATE) CREAM [CURAZENE, LLC]

BACLEZENE (NEOMYCIN SULFATE) CREAM [CURAZENE, LLC]
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NDC 52599-282-82, 52599-282-83
Set ID a82852eb-18e9-431a-b3d6-80abfdbf8662
Category HUMAN OTC DRUG LABEL
Packager Curazene, LLC
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

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

  • INDICATIONS & USAGE

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

  • PURPOSE

    Purpose: First Aid Antibiotic

  • WARNINGS

    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

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

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    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

  • PRINCIPAL DISPLAY PANEL

    Baclezene Carton

  • INGREDIENTS AND APPEARANCE
    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 finalpart333B06/19/2014
    Labeler - Curazene, LLC (005078008)
    Registrant - Curazene, LLC (005078008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corp.085752004manufacture(52599-282)

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