WESTERN FAMILY ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [WESTERN FAMILY FOODS INC]

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  • WESTERN FAMILY ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [WESTERN FAMILY FOODS INC]

WESTERN FAMILY ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [WESTERN FAMILY FOODS INC]
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NDC 55312-076-01
Set ID a325abf1-f239-4824-ba6c-cf1029ae1326
Category HUMAN OTC DRUG LABEL
Packager Western Family Foods Inc
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (each gram contains)Purpose
    Neomycin sulfate 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
    Pramoxine hydrochloride 10 mgTopical analgesic
  • Uses

    first aid to help prevent infection and for the temporary relief of pain or discomfort in

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week

    Ask a doctor before use

    • on deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • condition gets worse
    • condition persists for more than 7 days
    • condition clears up and occurs again within a few days
    • 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

    Adults and children 2 years of age and older:

    • 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

    Children under 2 years of age: consult a doctor

  • Other information

    • store at controlled room temperature
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    Western Family Foods, Inc.
    P.O. Box 4057, Portland, OR 97208

  • PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

    Antibiotic
    CREAM + PAIN RELIEF

    (Neomycin Sulfate
    Polymyxin B Sulfate-Pramoxine HCl)

    NET WT 1/2 OZ
    (14.2g)

    First Aid Antibiotic/Topical Pain Reliever

    Principal Display Panel - 14.2 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY   ANTIBIOTIC PLUS PAIN RELIEF
    neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-076
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Neomycin sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
    Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [iU]  in 1 g
    Pramoxine hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine hydrochloride10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-076-011 in 1 CARTON
    114.2 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/21/2012
    Labeler - Western Family Foods Inc (192166072)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(55312-076)
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