Label: BACITRACIN ZINC ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 December 13, 2020

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  • Active Ingredient

    Bacitracin Zinc 500 units

  • Purpose

    First aid antibiotic

  • USES

    First aid to help prevent infection in

    • scrapes  
    • minor cuts
    • burns
  • WARNINGS

    EXTERNAL USE ONLY

  • DO NOT USE

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

    • deep or puncture wounds
    • animal bites   
    • serious burns
  • STOP USE and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • symptoms persists for more than 1 week or clear up and occur again within a few days 
    • a rash or other allergic reaction develops
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS

    • clean 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 15° to 25°C (59° to 77°F).  
    • Before using any medication, read all label directions.

    Keep carton, it contains important information.

    Lot No./Exp. Date: see crimp of tube.

  • Inactive Ingredients

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • PRINCIPAL DISPLAY PANEL

    Bacitracin Zinc Ointment

    NET WT 0.5 OZ (14g)

    Bacitracin Zinz Ointment
  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-155
    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
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47046-155-021 in 1 CARTON12/09/2020
    1NDC:47046-155-0114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/09/2020
    Labeler - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(47046-155)
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