Label: ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

  • 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 December 3, 2020

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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: ask 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 1-800-910-6874

  • SPL UNCLASSIFIED SECTION

    Dist. by Target Corp.
    Mpls., MN 55403

  • PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

    up & up

    maximum strength
    antibiotic cream + pain relief
    neomycin sulfate, polymyxin b sulfate, pramoxine HCl
    first aid antibiotic / pain relieving cream

    helps prevent infection in minor cuts, scrapes and burns plus
    maximum strength pain relief

    NET WT 0.5 OZ (14.2 g)

    PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC PLUS PAIN RELIEF 
    neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-393
    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
    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:11673-393-011 in 1 CARTON10/16/2020
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B10/16/2020
    Labeler - TARGET Corporation (006961700)
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