Label: FIRST AID ANTIBIOTIC PLUS BURN RELIEF- bacitracinzinc,neomycinsulfate,polymxinbsulfate,pramoxinehci ointment

  • NDC Code(s): 69396-138-02
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Active Ingredient

    Pramoxine HCI

  • Purpose Section

    External Analgesic

  • Active Ingredient

    Polymyxin B Sulfate

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Bacitracin Zinc

  • Purpose

    First Aid Antibiotic

  • ACTIVE INGREDIENT

    Neomycin Sulfate

  • Purpose

    First Aid Antibiotic

  • Uses

    First Aid to help prevent infection and for the temporary relief of pain or discomfort in minor cuts, scrapes and burns.

  • Warnings

    For external Use Only

  • Do Not Use

    Do Not use

    • In the eyes
    • Over large areas of the body
    • If you are allergic to any of the ingredients
  • Ask Doctor before use if you have

    • Deep or puncture wounds
    • Animal Bites
    • Serious Burns
  • Stop Use and ask a doctor if

    • Condition persists or gets worse
    • You need to use longer than 1 week
    • A rash or other allergic reaction develops
    • symptoms persist for more than 1 week or clear up and occur again within a few days
  • Directions

    Adults and children 2 years of age and older:

    • Clean the affected area and dry thoroughly.
    • Apply a small amount of this product , an mount equal to the surgace 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 old: ask a doctor

  • Inactive Ingredients

    White Petrolatum

  • Questions

    Call 1-888-296-9067

  • Storage Information

    • Store at 20° to 25°C (68° to 77°F).
    • See carton or tube crimp for lot number and expiration date
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Other Information

    Distributed By:

    Trifecta Pharmaceuticals USA®

    101 NE Third Avenue, Suite 1500

    Fort Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

  • PRINCIPAL DISPLAY PANEL

    Globe First Aid Antibiotic and Burn Relief 2oz Rev13 082523 CDER

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTIBIOTIC PLUS BURN RELIEF 
    bacitracinzinc,neomycinsulfate,polymxinbsulfate,pramoxinehci ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-138
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-138-021 in 1 BOX09/04/2023
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00409/04/2023
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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