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

  • NDC Code(s): 0713-0622-31
  • Packager: Cosette Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 21, 2023

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  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
     Bacitracin zinc 500 units First aid antibiotic
     Neomycin 3.5 mg First aid antibiotic
     Polymyxin B sulfate 10,000 units First aid antibiotic
     Pramoxine hydrochloride 10.0 mg Topical analgesic

  • USES

    first aid to help prevent infection and provide temporary relief of pain or discomfort in minor • cuts • scrapes • burns

  • WARNINGS

    For external use only.
    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.

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • symptoms persist for more than 1 week, or clear up and occur again within a few days
    • 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

    • adults and children 2 years of age and older
         • 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
    • children under 2 years of age: consult a doctor

  • OTHER INFORMATION

    store at room temperature

  • INACTIVE INGREDIENT

    light mineral oil, white petrolatum

  • PRINCIPAL DISPLAY PANEL

    Triple Antibiotic Plus Ointment
    Polymyxin B Sulfate • Bacitracin Zinc • Neomycin Sulfate • Pramoxine HCl
    FIRST AID ANTIBIOTIC / PAIN RELIEVING OINTMENT
    Net Wt. 1 oz
    (28.4 g)

    Carton

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC PLUS  
    polymyxin b sulfate, bacitracin zinc, neomycin sulfate, pramoxine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0622
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin Zinc500 [USP'U]  in 1 g
    Neomycin (UNII: I16QD7X297) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Light Mineral Oil (UNII: N6K5787QVP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0713-0622-3128.4 g in 1 TUBE; Type 0: Not a Combination Product02/28/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00402/28/1998
    Labeler - Cosette Pharmaceuticals, Inc. (116918230)
    Registrant - Cosette Pharmaceuticals, Inc. (116918230)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosette Pharmaceuticals NC Laboratories, LLC079419931MANUFACTURE(0713-0622)
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