Label: KISS MY FACE KIDS FLUORIDE - BERRY SMART- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 74154-014-04
  • Packager: Windmill Health Products, LLC
  • 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 8, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Monofluorophosphate 0.76% w/w

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities

  • 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.
  • Directions

    adults and children 6 years of age and older:

    • brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor.
    • instruct children under 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.
  • 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

  • PRINCIPAL DISPLAY PANEL - 4.0 OZ Tube Carton

    ANTI-CAVITY FLUORIDE TOOTHPASTE

    KISS
    MY
    FACE®

    KIDS

    CAVITY FIGHTING

    SUGAR FREE

    with Tea Tree Oil
    & Aloe

    berry smart™

    VEGAN

    PARABEN & BPA FREE

    TRICLOSAN & SLS FREE

    NO ARTIFICIAL
    COLORS OR FLAVORS

    NET WT. 4.0 OZ

    PRINCIPAL DISPLAY PANEL - 4.0 OZ Tube Carton
  • INGREDIENTS AND APPEARANCE
    KISS MY FACE KIDS FLUORIDE - BERRY SMART 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74154-014
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    hydrated silica (UNII: Y6O7T4G8P9)  
    xylitol (UNII: VCQ006KQ1E)  
    cranberry (UNII: 0MVO31Q3QS)  
    zinc citrate (UNII: K72I3DEX9B)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    tea tree oil (UNII: VIF565UC2G)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    sorbic acid (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74154-014-041 in 1 CARTON02/18/2022
    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 Finalpart35502/18/2022
    Labeler - Windmill Health Products, LLC (831136267)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418MANUFACTURE(74154-014)
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