Label: DUAL ACTION CREAM- neomycinsulfate,polymyxinbsulfate,pramoxinehcl cream

  • NDC Code(s): 69396-071-01
  • Packager: Trifecta Pharmaceutical USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

If you are a consumer or patient please visit this version.

  • DRUG FACTS

  • Active Ingredient

    Neomycin 3.5mg

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Polymyxin B 10,000 Units

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Pramoxine HCL 10mg

  • Purpose

    External Analgesic

  • Uses

    First Aid to help prevent infection in minor cuts, scrapes and 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

  • 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 persists or gets worse
    • You need to use longer than 1 week
    • 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

    • Clean the affected area and dry thoroughly
    • 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

  • Questions

    For Questions please call 1 888 296 9067

  • 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:

    Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl Sterate, Light Mineral Oil, Petrolatum, Polyoxyethylene Lauryl Ether, Purified Water, Sodium Lauryl Sulfate.

  • Distributed By

    Trifecta Pharmaceuticals USA

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301

    www.trifecta-pharma.com

    Product of PRC

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

  • Packaging

    dual action ointment pain

  • INGREDIENTS AND APPEARANCE
    DUAL ACTION CREAM 
    neomycinsulfate,polymyxinbsulfate,pramoxinehcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-23 (UNII: N72LMW566G)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-071-011 in 1 BOX01/22/2021
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00401/06/2021
    Labeler - Trifecta Pharmaceutical USA LLC (079424163)