Label: VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC- neomycin sulfate ointment

  • NDC Code(s): 54312-019-31, 54312-019-35
  • Packager: Compania Internacional de Comercio, S.A. de C.V.
  • 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 August 4, 2016

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  • Drug Facts
  • Active ingredient (in each gram)

    Neomycin sulfate 5 mg (neomycin 3.5 mg)

    Purpose

    First aid antibiotic

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  • Uses

    First aid to help prevent infection in minor cuts, scrapes, and burns.

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  • 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 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

    • the condition persists or gets worse • a rash or other allergic reaction develops

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • 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

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  • Other information

    store at room temperature

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  • Inactive ingredients

    lanolin, methylparaben, petrolatum, propylparaben, vitamin A palmitate

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC 
    neomycin sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54312-019
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54312-019-35 1 in 1 CARTON 07/30/2016
    1 14 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:54312-019-31 1 in 1 CARTON 07/30/2016
    2 28 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 07/30/2016
    Labeler - Compania Internacional de Comercio, S.A. de C.V. (815039995)
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