Label: FIRST AID ANTIBIOTIC BACITRACIN WITH ZINC- 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 October 28, 2020

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  • ACTIVE INGREDIENT

    Active ingredient (each gram contains)                                                                        

    Bacitracin zinc        500 units

  • PURPOSE

    Purpose

    First Aid Antibiotic

  • INDICATIONS & USAGE

    Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • in the eyes
    • 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 DOCTOR

    Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.

  • STOP USE

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • 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
  • STORAGE AND HANDLING

    Other information

    • store at 15° to 25° C (59° to 77° F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera gel, light mineral oil and white petrolatum

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    FIRST AID RESEARCH CORP.

    Jupitor, FL 33478 Made in China

  • PRINCIPAL DISPLAY PANEL

    carton

  • PRINCIPAL DISPLAY PANEL

    carton2carton2

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTIBIOTIC BACITRACIN WITH ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75983-001
    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
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75983-001-141 in 1 CARTON02/14/2017
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:75983-001-281 in 1 CARTON02/14/2017
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/14/2017
    Labeler - First Aid Research Corp. (089405927)
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