KISS MY FACE KIDS BERRY SMART (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [KISS MY FACE, LLC]

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KISS MY FACE KIDS BERRY SMART (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [KISS MY FACE, LLC]
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NDC 65364-404-13
Set ID 82546aa6-8ee9-76b9-e053-2991aa0a88d6
Category HUMAN OTC DRUG LABEL
Packager Kiss My Face, LLC
Generic Name
Product Class
Product Number
Application Number PART355
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium Monofluorphosphate 0.76% w/w

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Uses

    Aids in the prevention of dental cavities

  • WARNINGS

    Warnings

    • Keep out of reach of children under 6 years of age.
    • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children over 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
    • Children under 6 years of age: consult a dentist or doctor
  • OTHER SAFETY INFORMATION

    Other information

    You may report a serious adverse event from using this product to Kiss My Face, LLC, 144 Main Street, Gardiner, NY 12525.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Glycerin, Hydrated Silica, Xylitol, Vaccinium Macrocarpon (Cranberry) Fruit Powder, Zinc Citrate, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Natural Flavor, Stevia Rebaudiana Extract, Cellulose Gum, Sorbic Acid

  • SPL UNCLASSIFIED SECTION

    Dist. Kiss My Face LLC, Gardiner, NY 12525 USA

  • PRINCIPAL DISPLAY PANEL

    KISS MY FACE®

    obsessively kids®

    Toothpaste with fluoride

    berry smart™

    no parabens, SLS, artificial colors or flavors...no kidding!

    NET WT. 4 OZ (113 g)

    kmf 65364-404 Kids Toothpaste Berry Smart

  • INGREDIENTS AND APPEARANCE
    KISS MY FACE  KIDS BERRY SMART
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-404
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    VACCINIUM MACROCARPON WHOLE (UNII: D11KO7O2DX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65364-404-131 in 1 CARTON08/01/2017
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/01/2017
    Labeler - Kiss My Face, LLC (041794279)
    Registrant - Lornamead Inc. (078584069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.078584069manufacture(65364-404)
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