Label: E ENZYME- sodium monofluorophosphate paste, dentifrice

  • 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 14, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: SODIUM MONOFLUOROPHOSPHATE 0.6%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, D-Sorbitol Liquefied, Colloidal Silcon Dioxide, ATTAPULGITE, PEG-1500, Sluminum chlorohydroxg allautonate, Aminocaparoid Acid, Sodium Saccharine, XYLITOL, Butyl-P oxybenzoare, Hydroxyapatite, Carbon hydrozen Sodium, GLYCERIN, Carboxymethylcellulose nattrium, Sulfuricacid, GRAPEFRUIT SEED OIL, GREEN TEA LEAF, PROPOLIS WAX, I-mentol, Optimint

  • PURPOSE

    Purpose: Anticavity, remove plaque, bad breath, whiten tooth - it improved taste keeps mouth feeling fresh and clean.

  • WARNINGS

    Warnings:
    It includes fluoride 792ppm
    Children under 6 years of age: use a pea-size amount. Do not swallow. Supervis children's brushing until capable of using without supervision.
    If children accidentally swallow more than used for brushing, ask a dentist or physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indication and usage:
    Aids in the prevention of cavities
    Helps prevent gingivitis and alveolar pyorrhea

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Adults at least a half-inch strip of the product onto a soft bristled tooth brush.
    Brush teeth thoroughly for at least 3 minutes twice a day.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    E ENZYME 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76414-010
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE1.2 g  in 200 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ATTAPULGITE (UNII: U6V729APAM)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76414-010-01200 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/01/2011
    Labeler - SAMJOKO SKYBLUE CO., LTD. (557804810)
    Registrant - SAMJOKO SKYBLUE CO., LTD. (557804810)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAMJOKO SKYBLUE CO., LTD.557804810manufacture
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