Label: KISS MY FACE WHITENING- sodium monofluorophosphate gel, 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 18, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • 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
    • plaque and tartar build-up
  • WARNINGS

    Warnings

    • Keep out of reach of children.
    • 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: Sorbitol, Glycerin, Hydrated Silica, Aqua, Xylitol, Aloe Barbadensis (Aloe Vera) Leaf Extract*, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Leaf Extract, Cetraria Islandica (Iceland Moss) Extract, Stevia Rebaudiana Extract, Natural Flavor, Mentha Piperita (Peppermint) Oil, Menthol, Ammonium Glycyrrhizate (Licorice), Xanthan Gum, Cellulose Gum, Sodium Methyl Cocoyl Taurate, Sodium Lauroyl Sarcosinate, Chlorophyllin-Copper Complex, Potassium Sorbate

    *Organic

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL

    KISS MY FACE®

    BREATH BLASTING FRESHNESS™

    WHITENING ANTICAVITY FLUORIDE Toothpaste with Xylitol

    WHITENS • REMOVES PLAQUE

    Cool Mint Gel

    Great Taste - No Triclosan/SLS

    antioxidant defenders™: Iceland moss extract • tea tree oil

    Net Wt. 4.5 oz (127.6 g)

    KMF 65364-400 Anticavity Whitening Gel Cool Mint

  • INGREDIENTS AND APPEARANCE
    KISS MY FACE  WHITENING
    sodium monofluorophosphate gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-400
    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
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    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)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    MENTHOL (UNII: L7T10EIP3A)  
    CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)  
    SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65364-400-271 in 1 CARTON03/01/2014
    1127.6 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/01/2014
    Labeler - Kiss My Face, LLC (041794279)
    Registrant - Lornamead Inc. (078584069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.078584069manufacture(65364-400)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!