Label: ANTIBIOTIC  - neomycin sulfate ointment 

  • Label RSS
  • NDC Code(s): 53210-1003-0
  • Packager: Morales Distributors Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

If you are a consumer or patient please visit this version.

  • Active ingredients (in each gram)

    Neomycin Sulfate 3.5mg

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  • Purpose

    First aid antibiotic

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  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
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  • Warnings

    For external use only

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  • Do not use

    • in the eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than one week unless directed by a doctor
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  • Consult a doctor in case of

    • deep or puncture wounds
    • animal bites
    • serious burns
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  • Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
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  • Keep out of reach of children

    in case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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  • 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
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  • Other information

    store at room temperature

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  • Inactive ingredients

    Liquid paraffin, Cethanol, Squalane, Purified lanolin, White petrolatum, Cetearyl alcohol, Tocopheryl acetate, Methylparaben, Propylparaben

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  • Package label

    NDC NO. 53210-1003-0
    Compare to Vitacilinia First Aid Antibiotic active ingredient

    MAXIMUM STRENGTH

    ANTIBIOTIC OINTMENT
    Neomycin Sulfate
    FIRST AID ANTIBIOTIC OINTMENT

    Net 1 oz (28.3g)

    Exclusively distributed by:
    Morales Distributors, Inc.
    Mayaguez, P.R. 00682

    Made in Korea

    package box label

    package box label

    tube label

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  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC  
    neomycin sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53210-1003
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    MINERAL OIL  
    SQUALANE  
    LANOLIN  
    PETROLATUM  
    CETOSTEARYL ALCOHOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53210-1003-0 1 in 1 BOX
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 09/25/2012
    Labeler - Morales Distributors Inc (127151731)
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