Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • Category: HUMAN OTC DRUG LABEL

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 Ingredients (in each gram)

    Bacitracin Zinc (400 units Bacitracin)

    Neomycin sulfate (3.5 mg Neomycin)

    Polymyxin B Sulfate (Polymyxin B 5000 units)

  • Purpose

    First aid antibiotic

    First aid antibiotic

    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
    • internally
    • 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:

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

    Stop use and ask a doctor if:

    • the condition persists or gets worse
    • 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 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
  • Other Information

    • store at room temperature (do not freeze)
    • do Not Use any Opened or Torn Packets
  • Inactive ingredient

    petrolatum

  • Questions or Comments?

    1 -800-456-7077

  • Principal Display Panel - 0.5 g Box Label

    NDC 70082-603-04

    dealmed

    Triple
    Antibiotic
    Ointment

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

    144
    PACKETS

    NET WT. 0.5g
    PER PACKET

    Principal Display Panel - 0.5 g Box Label
  • Principal Display Panel - 0.5g Pouch Label

    dealmed

    Triple Antibiotic
    Ointment

    0.5g (1/57 oz.)

    Dealmed • Brooklyn, NY

    www.dealmed.com

    Principal Display Panel - 0.5g Pouch Label
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70082-603
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I) bacitracin zinc400 [iU]  in 1 g
    neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297) neomycin sulfate3.5 mg  in 1 g
    polymyxin b sulfate (UNII: 19371312D4) (polymyxin b - UNII:J2VZ07J96K) polymyxin b5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70082-603-04144 in 1 BOX03/18/2022
    10.5 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(70082-603)
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