Label: ANTIBIOTIC- neomycin sulfate ointment

  • 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 September 28, 2012

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  • Active ingredients (in each gram)

    Neomycin Sulfate 3.5mg

  • Purpose

    First aid antibiotic

  • Uses

    First aid to help prevent infection 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
    • longer than one week unless directed by a doctor
  • Consult a doctor in case of

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

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

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

  • 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 room temperature

  • Inactive ingredients

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

  • 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

  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC  
    neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53210-1003
    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
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    SQUALANE (UNII: GW89575KF9)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53210-1003-01 in 1 BOX
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/25/2012
    Labeler - Morales Distributors Inc (127151731)
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