Label: BACITRACIN 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 March 6, 2014

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  • ACTIVE INGREDIENT

    Active ingredient                        Purpose
    Bacitracin Zinc 500 Units                Antibiotic

  • Purpose:

    First aid to help prevent infection.

  • Warnings:

    For external use only

    Dosage and Administration

    Directions:

    • clean the affected areas
    • apply a small amount of product (an amountb equal to the surface area of the tip of the finger) on the area 1 to 3 times daily.
    • may be covered with a sterile bandage

    Indications and Usage

    First aid to help prevent infection in:

    • minor cuts
    • scrapes
    • burns

    Stop Use and ask a doctor if:

    • the condition persists or gets worse, or if a rash or other allergic reaction develops.

    Do Not Use if:

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor
  • Ask a doctor before use:

    • in case of deep or puncture wounds
    • animal bites
    • serious burns

  • Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away
  • Other information

    • store at controlled room temperature 15°-30° C (59°-86° F)
  • Inactive ingredients

    Light Mineral Oil, White Petrolatum

  • Principal Display Panel

    Kinray Bacitracin Ointment:

    KR1163 Bacitracin.jpg

    KR1163 Bacitracin

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-079
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-079-0128.35 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/02/2013
    Labeler - Kinray Inc. (012574513)
    Registrant - Dynarex Corporation (008124539)
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