Label: BACITRACIN ZINC ointment

  • NDC Code(s): 52000-059-03
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 14, 2024

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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:52000-059
    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:52000-059-031 in 1 CARTON12/09/2020
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/09/2020
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Savvy Care & Cosmetics Pvt. Ltd. (915039748)
    Establishment
    NameAddressID/FEIBusiness Operations
    Savvy Care & Cosmetics Pvt. Ltd.915039748manufacture(52000-059)
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