Label: BACITRACIN ZINC ointment

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 15, 2017

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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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