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
  • 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 September 1, 2023

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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
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  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 finalpart333B09/04/2023
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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