BACITRACIN OINTMENT [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]

BACITRACIN OINTMENT [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]
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NDC 50382-005-01, 50382-005-02, 50382-005-03, 50382-005-04
Set ID 68449090-6c59-4046-b721-ebe572de0595
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Priva Te Limited
Generic Name
Product Class
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active ingredient               Purpose
    Bacitracin 500 Units                Antibiotic

  • Purpose:

    First aid to help prevent infection.

  • Warnings:

    For external use only

    Dosage and Administration

    Directions:

    • clean the affected areas
    • apply a small amount of product (an amountb 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

    Indications and Usage

    First aid to help prevent infection in:

    • minor cuts
    • scrapes
    • burns

    Stop Use and ask a doctor if:

    • the condition persists or gets worse, or if a rash or other allergic reaction develops.

    Do Not Use if:

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

    Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away

  • Ask a doctor before use:

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

  • Other information

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

    Light Mineral Oil, White Petrolatum

  • Principal Display Panel

    Bacitracin Ointment:

    Gal Bacitracin.jpg

    Gal Bacitracin

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-005-0128.35 g in 1 TUBE
    2NDC:50382-005-0214.17 g in 1 TUBE
    3NDC:50382-005-0356.7 g in 1 TUBE
    4NDC:50382-005-04113.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/02/2013
    Labeler - Galentic Pharma (India) Priva Te Limited (918531450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Priva Te Limited918531450manufacture(50382-005)

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