GOODSENSE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.]

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  • GOODSENSE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.]

GOODSENSE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.]
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NDC 50804-076-01
Set ID 3d79ece7-6b24-4aac-a8a3-e6cdcd605d27
Category HUMAN OTC DRUG LABEL
Packager Geiss, Destin & Dunn, 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 (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 FINALpart333B03/21/2012
    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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