VITACILINA (NEOMYCIN) OINTMENT [TERESA CECENA DBA GENESIS]

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VITACILINA (NEOMYCIN) OINTMENT [TERESA CECENA DBA GENESIS]
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NDC 69772-019-31, 69772-019-32, 69772-019-35
Set ID 1622ca25-3f6d-6158-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Teresa Cecena DBA Genesis
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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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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