EQUALINE ANTIBIOTIC PLUS PAIN RELIEF FOR KIDS (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [SUPERVALU INC]

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  • EQUALINE ANTIBIOTIC PLUS PAIN RELIEF FOR KIDS (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [SUPERVALU INC]

EQUALINE ANTIBIOTIC PLUS PAIN RELIEF FOR KIDS (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [SUPERVALU INC]
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NDC 41163-076-11
Set ID 832b75f6-3267-4ec0-a18e-246ff773d6ae
Category HUMAN OTC DRUG LABEL
Packager Supervalu 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 mgExternal 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

    Ask a 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
    • symptoms persist for more than 1 week, or clear up and occur again within a few days
    • 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 20° to 25°C (68° to 77°F)
    • 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 1-877-932-7948

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    SUPERVALU INC.
    EDEN PRAIRIE,
    MN 55344 USA

  • PRINCIPAL DISPLAY PANEL - 14.2g Tube Carton

    equaline®

    compare to the active ingredients in
    Neosporin® + Pain Relief*

    NDC 41163-076-11
    maximum strength

    antibiotic cream
    + pain relief for kids

    neomycin sulfate-polymyxin B sulfate-pramoxine HCl
    first aid antibiotic/pain relieving cream

    NET WT

    1/2 OZ (14.2g)

    Principal Display Panel - 14.2g Tube Carton
  • INGREDIENTS AND APPEARANCE
    EQUALINE   ANTIBIOTIC PLUS PAIN RELIEF FOR KIDS
    neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-076
    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:41163-076-111 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 - Supervalu Inc (006961411)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(41163-076)
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