Label: 365 EVERYDAY VALUE KIDS FLOURIDE- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 42681-5276-9
  • Packager: Whole Foods Market, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium monofluorophosphate 0.76%

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Use

    aids in the prevention of dental cavities

  • WARNINGS

    Warning

    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.

    • 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 sauroyl sarcosinate, natural flavors.

  • STORAGE AND HANDLING

    Other information

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

    Tamper evident, use only if seal is intact.

  • QUESTIONS

    Questions or comments?

    • customer.questions@wholefoods.com
    • 1 (844) 936-8255
  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    WHOLE FOODS MARKET

    AUSTIN, TX 78703

    www.wholefoods.com

    PRODUCT OF USA

  • Principal Display Panel

    Carton R1

    kid's fluoride toothpaste

    strawberry

    PROTECTS AGAINST CAVITIES

    HELPS FIGHT TARTAR

    MADE WITHOUT DYES

    MADE WITHOUT SODIUM LAURYL OR LAURETH SULFATE

    NET WT 4.2 OZ (119g)

  • INGREDIENTS AND APPEARANCE
    365 EVERYDAY VALUE  KIDS FLOURIDE
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42681-5276
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.13 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:42681-5276-9119 g in 1 TUBE; Type 0: Not a Combination Product03/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/06/2019
    Labeler - Whole Foods Market, Inc. (196175616)
    Registrant - Lornamead, Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(42681-5276)
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