Label: KIDS STRAWBERRY FTP- 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 March 10, 2022

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  • ACTIVE INGREDIENT

    Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion) .................. Anticavity

  • INDICATIONS & USAGE

    Use

    aids in the prevention of dental cavities

    Warning

    If more than used for brushing is accidentally swalloed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children under 6 years of age.

    Directions

    Adults and children 2 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 2 years of age: consult a dentist or doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients

    glycerin, water, calcium carbonate, hydrated silica carrageenan, sodium lauroyl sarcosinate, natural flavors

  • Other Information

    Store in a cool, dry place. Keep tube capped when not in use.

  • PRINCIPAL DISPLAY PANEL

    Tube R2

  • INGREDIENTS AND APPEARANCE
    KIDS STRAWBERRY FTP 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-417
    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
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-417-79119 g in 1 TUBE; Type 0: Not a Combination Product10/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/31/2019
    Labeler - Albertsons (009137209)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(21130-417) , pack(21130-417)