Label: MULTI ACTION- bacitracinzinc,neomycinsulfate,polymyxinbsulfate,pramoxinehcl ointment

  • NDC Code(s): 63868-912-01
  • Packager: Chain Drug Marketing Association Inc.
  • 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 May 23, 2023

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  • DRUG FACTS

  • Active Ingredient

    Bacitracin Zinc 500 Units

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Neomycin Sulfate 3.5mg

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Polymyxin B Sulfate 10,000 Units

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Pramoxine HCL 10mg

  • Purpose

    Pain Reliever

  • Uses

    Helps prevent infection in and temporarily relieves pain due to minor cuts, scrapes and burns.

  • Warnings

    For external use only. Do not use:

    • If you are allergic to any of the ingredients
    • in or near the eyes
    • on large areas of the body

  • Ask a Doctor before Use

    Ask Doctor before use if you have:

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
  • Stop Use and ask a Doctor if:

    • Condition lasts or gets worse
    • Symptoms last for more than 7 days or clear up and come back within a few days
    • A rash or other allergic reaction develops
  • When using this product

    Do not use longer than 1 week

  • 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 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: ask a doctor

  • Other Information

    • To Open: Unscrew cap, pull tab to remove foil seal
    • Store at 20° to 25°C (68° to 77°F)
    • See carton or tube crimp for lot number and expiration date
  • Inactive Ingredient:

    Cocoa Butter, Levant Cottonseed Oil, Olive Oil, Petrolatum, Sodium pyruvate, vitamin E

  • Questions?

    Call 1-800-935-2362

  • Other Information

    Distributed By

    CDMA Inc.

    Novi, MI 48375

    www.qualitychoice.com

    This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin® Plus Pain Itch Scar.

  • Packaging

    qc-triple-antibiotic-1oz-CDER 4

  • INGREDIENTS AND APPEARANCE
    MULTI ACTION 
    bacitracinzinc,neomycinsulfate,polymyxinbsulfate,pramoxinehcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-912
    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 SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-912-011 in 1 BOX08/31/2022
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/30/2022
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
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