Label: SINGLE ANTIBIOTIC- bacitracin zinc ointment

  • NDC Code(s): 61010-4404-1
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 14, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    ■ In the eyes or apply over large areas of the body

    ■ If you are allergic to any of the ingredients

    ■ Longer than 1 week unless directed by a doctor

    Ask a doctor before use if you havedeep or puncture wounds, animal bites, or serious burns

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

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Clean the affected area. Apply a small amount (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

  • Inactive Ingredients

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • Principal Display Panel – Tube Label

    Safetec ®

    Single Antibiotic Ointment

    First Aid Infection Protection with Bacitracin Zinc

    Net Wt. 1 oz. (28.4g)

    Reorder No. 53301

    Manufactured for: Safetec of America, Inc.

    Buffalo, NY 14215 | 1-800-456-7077

    Made in IndiaKD/503

    Figure
  • INGREDIENTS AND APPEARANCE
    SINGLE ANTIBIOTIC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4404
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-4404-128.4 g in 1 TUBE; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00411/01/2019
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-4404)
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