Label: SANITEX MVP FOAM ANTI-BACTERIAL- triclosan soap

  • NDC Code(s): 52007-100-03, 52007-100-04
  • Packager: Vectair Systems, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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  • Active Ingredient

    Triclosan 0.3% w/w

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  • Purpose

    Skin Antimicrobial

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  • Use

    reduces amount of bacteria on hands

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  • Warnings

    For external use only. Do not use in eyes.

    Discontinue use if irritation & redness develop. If condition persists for more than 72 hours, consult a physician.

    Not for use on children under 6 months of age.

    For institutional & professional use only.

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  • Directions

    • Wet hands and forearms.
    • Apply a palmful to hands & forearms.
    • Scrub thoroughly for at least 15 seconds.
    • Rinse completely & dry.
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  • Inactive Ingredients

    Water, Sodium Laureth Sulfate, Propylene Glycol, Sodium Cumenesulfonate, Sodium Chloride, Chloroxylenol, DMDM Hydantoin, Fragrance, Yellow 5, Blue 1

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  • INGREDIENTS AND APPEARANCE
    SANITEX MVP FOAM ANTI-BACTERIAL 
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52007-100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 3.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURETH SULFATE  
    PROPYLENE GLYCOL  
    SODIUM CUMENESULFONATE  
    SODIUM CHLORIDE  
    CHLOROXYLENOL  
    DMDM HYDANTOIN  
    FD&C YELLOW NO. 5  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color green (yellow-green (dispensed as a white foam)) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52007-100-04 4 in 1 BOX
    1 1000 mL in 1 BOTTLE, PUMP
    2 NDC:52007-100-03 3 in 1 BOX
    2 1200 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 09/24/2012
    Labeler - Vectair Systems, Inc. (805347296)
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