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
  • 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 November 29, 2022

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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)

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  • Package Labeling: (54312-019-14)

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  • Package Labeling:

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  • Package Labeling:

    Outer 4inner 4

  • 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 finalpart333B07/30/2016
    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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