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 May 6, 2014

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  • ACTIVE INGREDIENT

    Active ingredient               Purpose
    Bacitracin 500 Units                Antibiotic

  • Warnings:

    For external use only

    Dosage and Administration:

    • clean the affected areas
    • apply a small amount of product (an amount 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

    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 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

    Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away

  • Purpose

    First aid to help prevent infection in:
    Minor cuts
    scrapes
    burns

  • Indications and Usage

    Ask a doctor before use:

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

  • Other information

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

    Light Mineral Oil, White Petrolatum

  • Principal Display Panel

    Bacitracin Ointment:

    bacitracin-galentic-ointment-01.jpg

    1162_1163_Bacitracin_Ointment

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-219-0172 in 1 CASE
    128.35 g in 1 TUBE
    2NDC:67777-219-0472 in 1 CASE
    214.17 g in 1 TUBE
    3NDC:67777-219-0612 in 1 CASE
    3144 in 1 BOX
    30.5 g in 1 PACKET
    4NDC:67777-219-0712 in 1 CASE
    4144 in 1 BOX
    40.9 g in 1 PACKET
    5NDC:67777-219-0572 in 1 CASE
    556.7 g in 1 TUBE
    6NDC:67777-219-0272 in 1 CASE
    6113.4 g in 1 TUBE
    7NDC:67777-219-0312 in 1 CASE
    7425.3 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/01/2009
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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