BACITRACIN ZINC OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

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BACITRACIN ZINC OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
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NDC 50382-006-11, 50382-006-12, 50382-006-13, 50382-006-16, 50382-006-20
Set ID 4a92eec1-eb71-4aef-b6fa-b7257ecc0984
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Private Limited
Generic Name
Product Class
Product Number
Application Number PART333B
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  • • ACTIVE INGREDIENT

    • Active Ingredient (each gram contains)
      Bacitracin Zinc 500 units
  • • PURPOSE

    First 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
    • longer than 1 week unless directed by a doctor

    • Ask a doctor before use

    in case of deep or puncture wounds, animal bites, or serious burns

    • Stop use and ask a doctor if

    • 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 area
    • Apply a small amount of this 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 15° to 30°C (59° to 86°F)
    • Lot No. & Exp. Date. See box or crimp of tube.
  • • INACTIVE INGREDIENT

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • 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, Gujarat. India

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Galentic

    Bacitracin
    Ointment
    FIRST AID ANTIBIOTIC

    BACITRACIN
    ZINC

    Helps to Heal Burns, Scrapes & Cuts
    Prevents Infections

    NET WT.
    1 OZ. (28g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-006-11144 in 1 CARTON08/07/2017
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50382-006-121 in 1 CARTON08/07/2013
    214.2 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:50382-006-131 in 1 CARTON08/07/2013
    328 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:50382-006-161 in 1 CARTON08/07/2013
    4113 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:50382-006-2012 in 1 CASE08/07/2017
    5425 g in 1 JAR; 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(50382-006) , manufacture(50382-006) , pack(50382-006) , repack(50382-006) , sterilize(50382-006)
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