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Bacitracin zinc (Qualitest Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
OINTMENT 1 TUBE in 1 CARTON (0603-0441-50) > 28.4 g in 1 TUBE Label Information

Complete Bacitracin zinc Information

  • Active ingredient (in each gram)

    Bacitracin zinc, USP 500 units


  • Purpose

    First aid antibiotic


  • Uses

    First aid to help reduce the risk of infection in minor:

    • cuts
    • scrapes
    • burns

  • Warnings


  • For external use only


  • DO NOT USE

    Do not use if you are allergic to any of the ingredients


  • Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

  • When using this product

    • do not use in the eyes
    • do not apply over large areas of the body

  • Stop use and ask a doctor if

    • you need to use more 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 right away.


  • Directions

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

  • Other information

    • store at 15°- 30°C (59°- 86°F)
    • lot number and expiration date: See crimp of tube or box

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.


  • Inactive ingredients

    mineral oil, white petrolatum


  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 5/15 R7
    8260300  0441


  • PRINCIPAL DISPLAY PANEL

    This is an image of the carton for Bacitracin Zinc Ointment, USP.

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0441
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-0441-50 1 in 1 CARTON 09/01/2001 05/31/2018
    1 28.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333B 09/01/2001 05/31/2018
    Labeler - Qualitest Pharmaceuticals (011103059)
    Establishment
    Name Address ID/FEI Business Operations
    Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE(0603-0441)