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.P.I de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Drug Facts


  • Active ingredient (in each gram)

    Neomycin sulfate 5 mg (neomycin 3.5 mg)

    Purpose

    First aid antibiotic

  • Uses

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

  • 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

  • Other information

    store at room temperature

  • Inactive ingredients

    lanolin, methylparaben, petrolatum, propylparaben, vitamin A palmitate

  • Package Labeling: (54312-019-35)

    LabelLabel tube

  • Package Labeling: (54312-019-31)

    LabelLabel tube

  • INGREDIENTS AND APPEARANCE
    VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC 
    neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54312-019-351 in 1 CARTON07/30/2016
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:54312-019-311 in 1 CARTON07/30/2016
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00407/30/2016
    Labeler - Compania Internacional de Comercio, S.A.P.I de C.V. (822165213)
    Establishment
    NameAddressID/FEIBusiness Operations
    Compania Internacional de Comercio, S.A.P.I de C.V.822165213manufacture(54312-019)
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