BACITRACIN ZINC (FIRST AID ANTIBIOTIC) OINTMENT [DYNAREX CORPORATION]

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BACITRACIN ZINC (FIRST AID ANTIBIOTIC) OINTMENT [DYNAREX CORPORATION]
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NDC 67777-008-10, 67777-008-20, 67777-008-30, 67777-008-50, 67777-008-60
Set ID 82cf8dd0-eef6-5871-e053-2991aa0a38cf
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART333B
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  • Active Ingredient

    Bacitracin Zinc (500 units in each gram)

  • Purpose

    First Aid Antibiotic

  • Uses

    First aid to help prevent infection in minor cuts, scrapes, and burns

  • Warnings

    For external use only

    Do not use

    • In the eyes or apply over large areas of the body
    • If you are allergic to any of the ingredients
    • Longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

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

    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 room temperature
    • Avoid excessive heat and humidity
    • Tamper Evident. Do not use if inner seal is torn, cut or opened.
  • Inactive Ingredients

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • 1171 Label

    1171 BX MASTER

  • 1172 Label

    1172 Bacitracin Zinc

  • 1173 Label

    1173 Bacitracin Zinc Ointment

  • 1175 Label

    1175 Bacitracin Zinc

  • 1176 Label

    1176 Bacitracin Zinc

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    first aid antibiotic ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  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:67777-008-101728 in 1 CASE02/16/2018
    1144 in 1 BOX
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67777-008-2072 in 1 CASE02/16/2018
    21 in 1 BOX
    214.2 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:67777-008-3072 in 1 CASE02/16/2018
    31 in 1 BOX
    328.4 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:67777-008-5072 in 1 CASE02/16/2018
    41 in 1 BOX
    4113 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:67777-008-6012 in 1 CASE02/16/2018
    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 finalpart333B02/16/2018
    Labeler - Dynarex Corporation (008124539)
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