Label: SINGLE ANTIBIOTIC WITH BACITRACIN- 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 March 8, 2022

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  • Active Ingredient (in each gram)

    Bacitracin zinc (500 units bacitracin)

  • Purpose

    First Aid Antibiotic

  • Uses:

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

  • Warnings:

    For external use only.

    Keep out of reach of children.

    If ingested, get medical help or contact a Poison Control Center directly.

    Do Not Use:

    • in the eyes or over large areas of the body, or on puncture wounds, animal bites or serious burns
    • for more than 1 week unless directed by a doctor
    • if allergic to any of the ingredients

    Stop use, ask a doctor if:

    • condition persists or gets worse
    • a rash or allergic reaction develops
  • Directions:

    • clean affected area
    • apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily
    • may cover with a sterile bandage
  • Inactive ingredients:

    mineral oil, petrolatum

  • Questions or Comments?

    1-800-456-7077

  • Principal Display Panel - 0.9g Box Label

    NDC 70082-601-02

    dealmed

    Bacitracin
    Ointment

    First Aid to help prevent
    infection in minor cuts,
    scrapes and burns

    144
    Packets

    NET WT. 0.9g
    PER PACKET

    Principal Display Panel - 0.9g Box Label
  • Principal Display Panel - 0.9g Pouch Label

    dealmed

    Bacitracin
    Ointment

    0.9g (1/32 oz.)

    Dealmed • Brooklyn, NY

    www.dealmed.com

    Principal Display Panel - 0.9g Pouch Label
  • INGREDIENTS AND APPEARANCE
    SINGLE ANTIBIOTIC WITH BACITRACIN 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70082-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I) bacitracin zinc400 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70082-601-02144 in 1 BOX03/18/2022
    10.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/18/2022
    Labeler - Dealmed Medical Supplies LLC (068586441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(70082-601)
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