BACITRACIN ZINC OINTMENT [DYNAREX CORPORATION]

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BACITRACIN ZINC OINTMENT [DYNAREX CORPORATION]
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NDC 67777-220-01, 67777-220-02, 67777-220-03, 67777-220-04, 67777-220-05, 67777-220-07
Set ID 8587c2e3-cfa9-4a58-a4bd-ce2a8bda9464
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART333
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  • ACTIVE INGREDIENT

    Active ingredient                                               Purpose
    Bacitracin Zinc (500 Units in each gram)               First Aid Antibiotic

  • Warnings:

    For external use only

    DOSAGE & ADMINISTRATION:

    • clean the affected areas, Apply a small amount of product (an amount 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

    Stop use and ask a doctor if

    Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops.

    Indications & Usage:

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

    Keep out of reach of children

    KEEP OUT OF REACH OF CHILDREN

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

  • Purpose:

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

  • Other information

    • store at controlled room temperature
    • Avoid excessive heat and humidity
    • Tamper Evident. Do not use if inner seal is torn, cut or open.
  • Ask a doctor if

    Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

  • Inactive ingredients

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • Principal Display Panel

    Dynarex Bacitracin Zinc Ointment:

    1175 ESG.jpg

    1172_1173_1175_1176_Bacitracin_Zinc_Ointment

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-220
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-220-0228.35 g in 1 TUBE; Type 0: Not a Combination Product12/01/2009
    2NDC:67777-220-0314.17 g in 1 TUBE; Type 0: Not a Combination Product12/01/2009
    3NDC:67777-220-04113.4 g in 1 TUBE; Type 0: Not a Combination Product12/01/2009
    4NDC:67777-220-07425.3 g in 1 JAR; Type 0: Not a Combination Product12/01/2009
    5NDC:67777-220-050.5 g in 1 PACKET; Type 0: Not a Combination Product12/01/2009
    6NDC:67777-220-010.9 g in 1 PACKET; Type 0: Not a Combination Product12/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/01/2009
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Pvt. Ltd.864201135manufacture(67777-220)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Private Limited650970176manufacture(67777-220)
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