Label: PREMIER VALUE MAX STRENGTH ANTIBIOTIC PLUS PAIN RELIEF- premier value neomycin sulfate, polymyxin b sulfate, pramoxine hcl cream

  • NDC Code(s): 68016-296-05
  • Packager: Pharmacy Value Alliance 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 May 9, 2023

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  • DRUG FACTS

  • 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

    External Analgesic

  • Uses

    First Aid to help prevent infection in minor:

    • Cuts
    • Scrapes
    • Burns
  • Warnings

    For external use only. Do not use:

    • In eyes
    • Over large areas of the body
    • If you are allergic to any of the ingredients

  • 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
  • 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.

  • Questions or Comments

    Call 1-866-923-4914

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

    Distributed By:

    Pharmacy Value Alliance, LLC.

    407 East Lancaster Avenue

    Wayne, PA. 19087

    Product of PRC

  • Packaging

    pv antibiotic cream + pain 05oz-PV03636

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE MAX STRENGTH ANTIBIOTIC PLUS PAIN RELIEF 
    premier value neomycin sulfate, polymyxin b sulfate, pramoxine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-296
    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
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-296-051 in 1 BOX09/22/2019
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/22/2019
    Labeler - Pharmacy Value Alliance LLC (101668460)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
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