BACITRACIN OINTMENT [BLOSSOM PHARMACEUTICALS]

BACITRACIN OINTMENT [BLOSSOM PHARMACEUTICALS]
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NDC 61767-219-01
Set ID 54a400eb-a0e7-465f-9bc5-c526d169a961
Category HUMAN OTC DRUG LABEL
Packager Blossom Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active ingredient                                                                    Purpose
    Bacitracin Zinc (Equal to 500 Bacitracin Units)                          First Aid 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
  • Ask a doctor before use:

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

  • Keep out of reach of children

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

    BP Bacitracin.jpg

    Bacitracin

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61767-219-0128.35 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/06/2014
    Labeler - Blossom Pharmaceuticals (677381470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blossom Pharmaceuticals677381470manufacture(61767-219)

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