Label: VITACILINA- neomycin ointment

  • Category: HUMAN OTC DRUG LABEL

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 February 3, 2017

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  • ACTIVE INGREDIENT

    NEOMYCIN SULFATE 5mg

  • PURPOSE

    PURPOSE

    Antibootic

  • USER SAFETY WARNINGS

    USES

    Frist aid to help prevent infection in* minor cuts*scrapes*burns

  • WARNINGS

    Warnings

    For external Use only

  • DO NOT USE

    DO NOT USE

    In the eyes or apply over large areas of the body

    Longer that a weel unless directed by doctor

  • STOP USE

    Stop Use

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

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental ingestion, seek professional assistance or contac a poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    Clean the affected area. Apply a small amout of the product ( an amount equeal to the surface area of the tip of finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.

  • INDICATIONS & USAGE

    Clean the affected area. Aplly a small amount of the product on the area 1 to 3 times daily.

    May be covered with a sterile bandage

  • INACTIVE INGREDIENT

    Lanolin, Methylparaben, Petrolatum, propylparaben, vitamin A palmitate

  • PRINCIPAL DISPLAY PANEL

    Vitacilina

  • INGREDIENTS AND APPEARANCE
    VITACILINA 
    neomycin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-019
    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)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-019-351 in 1 CARTON05/15/2015
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69772-019-311 in 1 CARTON05/20/2015
    228 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:69772-019-321 in 1 CARTON02/03/2017
    332 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/15/2015
    Labeler - Teresa Cecena DBA Genesis (078760958)
    Registrant - Teresa Cecena (078760958)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teresa Cecena DBA Genesis078760958relabel(69772-019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Farmaqro SA de CV588161468manufacture(69772-019)
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