Label: THERACARE BACITRACIN ZINC- first aid antibiotic ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Active Ingredient

    Bacitracin Zinc (500 units in each gram)

  • Purpose

    First Aid Antibiotic

  • Uses

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

  • Warnings

    For external use only

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    deep or puncture wounds, serious burns, animal bites

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • the condition persists or gets worse
    • rash or other allergic reaction develops

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

    When using this product

    use as directed

  • Directions

    adults or children 2 years of age and older:

    • 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.

    children under 2 years of age:ask a doctor

  • Other Information

    • store at room temperature 20-25C (68-78F)
    • do not use if tube seal under cap is broken
  • Inactive Ingredients

    Light mineral Oil, Hard Paraffin, Petrolatum

  • Questions and comments?

    866-326-1313

  • Label

    label

  • INGREDIENTS AND APPEARANCE
    THERACARE BACITRACIN ZINC 
    first aid antibiotic ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-230-011 in 1 BOX05/01/2023
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00405/01/2023
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-230)
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