Label: KISS MY FACE TRIPLE ACTION- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 0.15% w/w fluoride ion

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Uses

    Aids in the prevention of

    • dental cavities
    • plaque and tartar build-up
  • WARNINGS

    Warnings

    • Keep out of reach of children under 6 years of age.
    • If you accidentally swallow more than used for brushing, contact a Poison Control Center or seek professional assistance immediately.
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply at least a 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day or as recommended by a dentist or doctor.
    • 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 Glycerin, Aqua, Hydrated Silica, Sorbitol, Xylitol, Calcium Carbonate, Olea Europaea (Olive) Leaf Extract, Cetraria Islandica (Iceland Moss) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Stevia Rebaudiana Extract, Natural Flavor, Xanthan Gum, Sodium Methyl Cocoyl Taurate, Sodium Lauroyl Sarcosinate, Titanium Dioxide, Zinc Citrate, Potassium Sorbate

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL

    KISS MY FACE®

    BREATH BLASTING FRESHNESS™

    TRIPLE ACTION ANTICAVITY FLUORIDE Toothpaste with Xylitol

    REMOVES PLAQUE • WHITENS • PREVENTS TARTAR BUILD-UP

    Fresh Mint Paste

    Great Taste - No Triclosan/SLS

    antioxidant defenders™: tea tree oil • olive leaf extract

    Net Wt.. 4.1 oz (116.2 g)

    KMF 65363-402 Triple Action Anticavity Toothpaste Fresh Mint

  • INGREDIENTS AND APPEARANCE
    KISS MY FACE  TRIPLE ACTION
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-402
    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
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65364-402-161 in 1 CARTON08/01/2017
    1116.2 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(65364-402)
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