Label: KISS MY FACE ENAMEL EXTRA- potassium nitrate, sodium fluoride gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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

    Potassium Nitrate 5.0% w/w

    Sodium Fluoride 0.243% w/w

  • PURPOSE

    Purpose

    Antihypersensitivity

    Anticavity

  • INDICATIONS & USAGE

    Uses

    • Builds increasing protection against painful due to cold, heat, acids, sweets or contact.
    • Aids in the prevention of plaque and tarter build-up.
  • WARNINGS

    Warnings

    • Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.

    • 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 one minute, preferably after each meal or at least 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 St, Gardiner NY 12525.

  • INACTIVE INGREDIENT

    Inactive ingredients Glycerin, Water, Sorbitol, Hydrated Silica, Xylitol, Calcium Glycerophosphate, Aloe Barbadensis (Aloe Vera) Leaf Extract*, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Leaf Extract, Stevia Rebaudiana Extract, Natural Flavor, Mentha Piperita (Peppermint) Oil, Menthol, Ammonium Glycyrrhizate (Licorice) Root Extract, Xanthan Gum, Cellulose Gum, Sodium Methyl Cocoyl Taurate, Sodium Lauroyl Saracosinate, Chlorophyllin-Copper Complex, Potassium Sorbate

  • SPL UNCLASSIFIED SECTION

    Dist: Kiss My Face LLC

    Gardiner, NY 12525 USA

  • PRINCIPAL DISPLAY PANEL

    KISS MY FACE

    BREATH BLASTING FRESHNESS

    ENAMEL EXTRA

    ANTICAVITY FLUORIDE Toothpaste with Xylitol

    Cool Mint Gel

    HELPS REHARDEN ENAMEL • WHITENS • REDUCES SENSITIVITY

    antioxidant defenders™: tea tree oil • olive leaf extract

    Net Wt. 4.5 oz (127.6 g)

    KMF 65364-403 Enamel Xtra Anticavity Toothpaste Cool Mint

  • INGREDIENTS AND APPEARANCE
    KISS MY FACE  ENAMEL EXTRA
    potassium nitrate, sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-403
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.243 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU)  
    SORBITOL (UNII: 506T60A25R)  
    AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHOL (UNII: L7T10EIP3A)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65364-403-271 in 1 CARTON04/01/2015
    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 not finalpart35604/01/2015
    Labeler - Kiss My Face, LLC (041794279)
    Registrant - Lornamead Inc. (078584069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.078584069manufacture(65364-403)
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