Label: SIMPLE TRUTH KIDS FLOURIDE- 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 July 19, 2021

If you are a consumer or patient please visit this version.

  • 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

    Tube R2simple truth

    KIDS' Fluoride Toothpaste

    PREVENTS CAVITIES

    STRAWBERRY

    no artificial colors, preservatives, flavors or sweeteners

    4.2 OZ (119g)

  • 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)