TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

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  • TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
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NDC 50382-023-11, 50382-023-12, 50382-023-13
Set ID 06dbbb55-9464-4c50-9fb1-cc1c4496c60a
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Private Limited
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • • ACTIVE INGREDIENT

    Active ingredient (in each gram)  Purpose
    Bacitracin Zinc 400 UnitsFirst Aid Antibiotic
    Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)First Aid Antibiotic
    Polymyxin B Sulfate 5000 UnitsFirst Aid Antibiotic
  • • USES

    first aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • • WARNINGS

    For external use only

    • DO NOT USE

    • in the eyes
    • if you are allergic to any of the ingredients
    • over large areas of the body

    • ASK A DOCTOR BEFORE USE IF YOU HAVE

    • Animal bites
    • Serious burns
    • Deep or puncture wounds

    • STOP USE AND ASK A DOCTOR IF

    • You need to use longer than 1 week
    • Condition persists or gets worse
    • Rash or other allergic reaction develops

    • KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • • DIRECTIONS

    • clean the affected areas
    • apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • • OTHER INFORMATION

    • store at controlled room temperature 15°-30° C (59°-86° F)
  • • INACTIVE INGREDIENTS

    White Petrolatum

  • SPL UNCLASSIFIED SECTION

    Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,
    Gandhidham-370 230, Gujrat. India

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Galentic

    Triple Antibiotic
    Ointment
    FIRST AID ANTIBIOTIC

    Helps Prevent Infection
    in Minor Cuts, Scrapes and Burns
    Bacitracin zinc, Neomycin Sulfate, Polymyxin-B Sulfate

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-023-11144 in 1 CARTON08/07/2017
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50382-023-121 in 1 CARTON08/07/2013
    214.2 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:50382-023-131 in 1 CARTON08/07/2013
    328 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/07/2013
    Labeler - Galentic Pharma (India) Private Limited (915110464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Private Limited650970176analysis(50382-023) , manufacture(50382-023) , pack(50382-023) , repack(50382-023) , sterilize(50382-023)
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