BACITRACIN OINTMENT [DYNAREX CORPORATION]

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BACITRACIN OINTMENT [DYNAREX CORPORATION]
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NDC 67777-116-10, 67777-116-20, 67777-116-30
Set ID 7f8752c7-6839-261d-e053-2991aa0a0c30
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART333B
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  • Active Ingredient

    Bacitracin (500 units in each gram)

  • Purpose

    First Aid Antibiotic

  • Use

    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

    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

  • Inactive ingredients

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • 1162 Label

    1162 Bacitracin Principal Display Panel

  • 1161 Label

    1161 Bacitracin Principal Display Panel

  • 1163 Label

    1163 Bacitracin

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500   in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-116-101728 in 1 CASE09/12/2016
    1144 in 1 BOX
    1900 mg in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67777-116-3072 in 1 CASE09/12/2016
    21 in 1 BOX
    228400 mg in 1 TUBE; Type 0: Not a Combination Product
    3NDC:67777-116-2072 in 1 CASE09/12/2016
    314000 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/12/2016
    Labeler - Dynarex Corporation (008124539)
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