Label: SIMPLE TRUTH KIDS FLOURIDE- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

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

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Use

    Helps protect against cavities

  • WARNINGS

    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

    Directions

    Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

    Children 2 to 6 years: use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).

    ​Children under 2 years of age: consult a dentist or physician.

  • INACTIVE INGREDIENT

    Inactive ingredients Glycerin, Water, Calcium Carbonate, Hydrated Silica, Natural Flavor, Carrageenan, Sodium Lauroyl Sarcosinate

  • STORAGE AND HANDLING

    Other information

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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY THE KROGER CO.

    CINCINNATI, OHIO 45202

  • PRINCIPAL DISPLAY PANEL

    simple truth

    KIDS' Fluoride Toothpaste

    PREVENTS CAVITIES

    STRAWBERRY

    no artificial colors, preservatives, flavors or sweeteners

    4.2 OZ (119g)

    Kroger Kids Strawberry-1821297R1

  • INGREDIENTS AND APPEARANCE
    SIMPLE TRUTH   KIDS FLOURIDE
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-146
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-146-79119 g in 1 TUBE; Type 0: Not a Combination Product02/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/25/2019
    Labeler - Kroger Company (006999528)
    Registrant - Lornamead, Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(30142-146)
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