Label: WHITENING KIT- sodium mfp kit

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 12, 2024

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  • ACTIVE INGREDIENT

    Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

  • PURPOSE

    Anticavity

  • INDICATIONS & USAGE

    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.

  • DOSAGE & ADMINISTRATION

    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

    glycerin, hydrated silica, water, sorbitol, pentasodium triphosphate, PVP, titanium dioxide, cellulose gum, flavor, cocamidopropyl betaine, sodium lauryl sulfate, potassium sorbate, sorbic acid, potassium acesulfame, sucralose, sodium hydroxide

  • PRINCIPAL DISPLAY PANEL

    Kit R1

  • INGREDIENTS AND APPEARANCE
    WHITENING KIT 
    sodium mfp kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-410
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-410-091 in 1 CARTON; Type 0: Not a Combination Product11/09/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 76.5 g
    Part 1 of 1
    WEEKEND WHITE TP 
    sodium mfp paste, dentifrice
    Product Information
    Item Code (Source)NDC:51316-411
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    176.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/09/2021
    Labeler - CVS (062312574)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(51316-410) , pack(51316-410)
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