Label: WALGREENS KIDS MULTI-ANTIBIOTIC WITH PAIN RELIEF CREAM- polymyxin b sulfate, neomycin sulfate, pramoxine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 19, 2022

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  • Drug Facts

  • Active ingredients (in each gram)       Purpose

    Neomycin Sulfate (3.5mg)                      First Aid Antibiotic
    Polymixin B Sulfate (10,000 units)           First Aid Antibiotic
    Pramoxine Hydrochloride (10 mg)            External Analgesic

  • Purpose 

    First Aid Antibiotic

    First Aid Antibiotic

     External Analgesic

  • Uses

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

    cuts
    scapes
    burns

  • Warnings

    For external use only 

  • Keep this and all drugs out of the reach of children

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    Adults and children 2 years of age 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 of age: ask a doctor
  • Other Information 

    store at 20° to 25°C (68° to 77°F)

  • Inactive ingredients 

    Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate SE, Methylparaben, Mineral Oil, Phosphoric Acid, Propylene Glycol, Purified Water, White Petrolatum

  • Questions? 

    Call 1-800-222-1087

  • Principal Display Panel -Tube

    Walgreens Children Multi Antibiotic +Pain Relief Cream    NDC 0363-2122-14

    Neomycin Sulfate /Polymxin B Sulfate /Pramoxine HCL 

    First Aid Anitbiotic / Pain Relieving Cream 

    NET WT 0.5 OZ (14.2g)

    280251_WAG_FA_817320_TripleAntibiotic_TUBE.jpg

  • Principal Dispaly Panel -Carton 

    Walgreens Children Multi Antibiotic +Pain Relief Cream NDC 0363-2122-14

    Neomycin Sulfate /Polymxin B Sulfate /Pramoxine HCL

    First Aid Anitbiotic / Pain Relieving Cream

    NET WT 0.5 OZ (14.2g)

    580251_WAG_FA_817320_TripleAntibiotic_BOX.jpg

  • INGREDIENTS AND APPEARANCE
    WALGREENS KIDS MULTI-ANTIBIOTIC WITH PAIN RELIEF CREAM 
    polymyxin b sulfate, neomycin sulfate, pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2122
    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
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2122-141 in 1 CARTON12/01/2022
    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 not finalpart34812/01/2022
    Labeler - Walgreens Company (008965063)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(0363-2122)
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