E ENZYME (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SAMJOKO SKYBLUE CO., LTD.]

E ENZYME (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SAMJOKO SKYBLUE CO., LTD.]
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NDC 76414-010-01
Set ID 742755fa-b013-40da-a204-075613931c02
Category HUMAN OTC DRUG LABEL
Packager SAMJOKO SKYBLUE CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART355
  • ACTIVE INGREDIENT

    Active ingredient: SODIUM MONOFLUOROPHOSPHATE 0.6%

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  • 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

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  • PURPOSE

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

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    Keep out of reach of children.

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  • INDICATIONS & USAGE

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

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  • 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.

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  • INGREDIENTS AND APPEARANCE
    E ENZYME 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76414-010
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 1.2 g  in 200 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76414-010-01 200 g in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 03/01/2011
    Labeler - SAMJOKO SKYBLUE CO., LTD. (557804810)
    Registrant - SAMJOKO SKYBLUE CO., LTD. (557804810)
    Establishment
    Name Address ID/FEI Business Operations
    SAMJOKO SKYBLUE CO., LTD. 557804810 manufacture
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