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

  • NDC Code(s): 50804-076-01
  • Packager: Geiss, Destin & Dunn, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)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 temporary relief of pain or discomfort in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    Not for prolonged use.

    Do Not Use

    • in the eyes, nose, or over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week unless directed by a doctor

    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 for more than 7 days, gets worse, or clears up and occurs again within a few days
    • a rash or other allergic reaction develops
    • redness, irritation, swelling, or pain persists or increases

    If pregnant or breast-feeding,ask a health professional before use.

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • 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
    • the affected area may be covered with a sterile bandage

    Children under 2 years of age: ask a doctor

  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • contents filled by weight, not volume
    • Tamper Evident:DO NOT USE IF FLAPS ON CARTON ARE NOT SEALED OR MISSING
  • Inactive ingredients

    cetearyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, purified water

  • Questions or comments?

    866-323-0107

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Geiss, Destin & Dunn, Inc
    Peachtree City, GA 30269

  • PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

    GOODSENSE ®
    NDC 50804-076-01

    Maximum Strength

    Antibiotic Cream + Pain Relief
    Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl
    First Aid Antibiotic Pain Relieving Cream

    Compare to active ingredients in
    Neosporin ®+ Pain Relief*

    100%
    SATISFACTION
    GUARANTEED

    NET WT 0.5 oz (14.2 g)

    PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    GOODSENSE  ANTIBIOTIC PLUS PAIN RELIEF
    neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-076
    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:50804-076-011 in 1 CARTON03/21/2012
    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 DrugM01703/21/2012
    Labeler - Geiss, Destin & Dunn, Inc. (076059836)
    Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196manufacture(50804-076)
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