Label: KISS MY FACE KIDS BERRY SMART- 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 February 20, 2019

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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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