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

  • Label RSS
  • 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

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 09/13

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  • VITACILINA NEOMYCIN SULFATE OINTMENT FIRST AID ANTIBIOTIC
  • Active Ingredients

    Neomycin Sulfate 5 mg (eq to 3.5 mg neomycin)

    Purpose

    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

    •Do not use

    in the eyes or apply over large areas of the body.

    •In Case of

    deep or puncture wounds animal bites or serious burns, consult a doctor.

    •Stop use

    and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops

    •Do not use

    longer than 1 week unless directed by a doctor

    Keep out of the reach of children.

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

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  • Directions

    Clean the affected area. Apply a small amount of the 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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  • Inactive ingredients

    lanolin, methylparaben, petrolatum, propylparaben, vitamin A palmitate

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  • VITACILINA NEOMYCIN SULFATE OINTMENT FIRST AID ANTIBIOTIC 14g (54312-019-35)| VITACILINA NEOMYCIN SULFATE OINTMENT FIRST AID ANTIBIOTIC 28g (54312-019-31)
  • INGREDIENTS AND APPEARANCE
    VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC 
    neomycin sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54312-019
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    LANOLIN  
    METHYLPARABEN  
    PETROLATUM  
    PROPYLPARABEN  
    VITAMIN A PALMITATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54312-019-35 1 in 1 CARTON
    1 14 g in 1 TUBE
    2 NDC:54312-019-31 1 in 1 CARTON
    2 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 08/28/2012
    Labeler - Compania Internacional de Comercio, S.A. de C.V. (815039995)
    Establishment
    Name Address ID/FEI Business Operations
    Farmaqro, S.A. de C.V. 588161468 manufacture(54312-019)
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