POMADA DE SULFA (NEOMYCIN SULFATE) OINTMENT [MENPER DISTRIBUTORS, INC.]

POMADA DE SULFA (NEOMYCIN SULFATE) OINTMENT [MENPER DISTRIBUTORS, INC.]
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NDC 53145-056-02
Set ID 216f4d22-e5e8-46c8-a4ef-8d1532792b56
Category HUMAN OTC DRUG LABEL
Packager Menper Distributors, Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active ingredient (in each gram)

    Neomycin  3.5 mg

  • PURPOSE

    Purpose

    First aid antibiotic

  • INDICATIONS & USAGE

    Uses

    first aid to help prevent infection in minor

    • cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only

    Do not use

    • in the eyes or apply 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 in case of deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reactions develop
  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    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
  • INACTIVE INGREDIENT

    Inactive ingredients

    methylparaben, propylparaben, vitamin E, white petrolatum

  • QUESTIONS

    Menper Distributs, Inc.

    11421 NW 107 St. Suite #24

    Miami Fl 33178

    www.menperdistributors.com

  • PRINCIPAL DISPLAY PANEL

    Pomada de Sulfa Label

  • INGREDIENTS AND APPEARANCE
    POMADA DE SULFA 
    neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-056
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-056-021 in 1 PACKAGE02/21/2012
    157 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/21/2012
    Labeler - Menper Distributors, Inc. (101947166)

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