Label: NEOSPORIN PLUS PAIN RELIEF FIRST AID ANTIBIOTIC/PAIN RELIEVING- neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

  • NDC Code(s): 69968-0055-1, 69968-0055-2
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Neomycin Sulfate (3.5 mg)First aid antibiotic
    Polymyxin B Sulfate (10,000 units)First aid antibiotic
    Pramoxine HCl (10 mg)External 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

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

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • 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 Centre 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)
    • product may settle
  • Inactive ingredients

    Water, Emulsifying Wax, Mineral Oil, Petrolatum, Propylene Glycol, Methylparaben, Sulfuric acid, Sodium Hydroxide

  • Questions?

    call 800-223-0182 or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Kenvue Brands LLC

    Summit, NJ 07901

  • PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton

    #1

    DOCTOR

    RECOMMENDED

    BRAND

    NEOSPORIN ®

    +

    PAIN RELIEF

    Maximum Strength

    Pain Relief

    Soothing Infection

    Protection

    Fast–Absorbing

    Cream

    NO STING

    CREAM

    FIRST AID ANTIBIOTIC/PAIN RELIEVING CREAM

    Neomycin Sulfate-Polymyxin B Sulfate-Pramoxine HCl

    NET WT. 1 OZ (28.3 g)

    Neosporin

  • INGREDIENTS AND APPEARANCE
    NEOSPORIN PLUS PAIN RELIEF  FIRST AID ANTIBIOTIC/PAIN RELIEVING
    neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0055
    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 [USP'U]  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)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SULFURIC ACID (UNII: O40UQP6WCF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0055-21 in 1 CARTON12/01/2009
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69968-0055-11 in 1 CARTON12/01/2009
    228.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/01/2009
    Labeler - Kenvue Brands LLC (118772437)
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