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

  • NDC Code(s): 55681-216-01, 55681-216-02
  • Packager: TWIN MED, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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  • Active Ingredients(in each gram)

    Bacitracin Zinc............400 units
    Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)
    Polymyxin B Sulfate ....5000 units

  • Purpose

    First Aid Antibiotic

  • Uses

    First aid to prevent infection in

    • Minor cuts
    • Scrapes
    • Burns
  • Directions

    • Clean the affected area
    • Apply small amount of this 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
  • Warnings

    For External Use Only.

    Do not use

    • In the eyes
    • If you are allergic to any of the ingredients
    • 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 or serious burns

    Stop use and ask a doctor if

    • The condition persists or gets worse
    • A rash or allergic reaction develops

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Centre right away

    Other information

    • Store at controlled room temperature 15 o - 30 oC(59 o--86 o F)
    • Avoid excessive heat and humidity
    • Tamper Evident
    • Do not use if packet is torn, cut or opened.

    Inactive Ingredients

    White Soft Paraffin

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  • INGREDIENTS AND APPEARANCE
    PROCURETRIPLE ANTIBIOTIC  TRIPLE ANTIBIOTIC
    bacitracin zinc neomycin sulfate polymyxin b ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 U  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55681-216-010.9 g in 1 PACKET; Type 0: Not a Combination Product09/22/2021
    2NDC:55681-216-0228.3 g in 1 TUBE; Type 0: Not a Combination Product08/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00402/05/2013
    Labeler - TWIN MED, LLC (009579330)
    Registrant - TWIN MED, LLC (009579330)
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