365 EVERYDAY VALUE KIDS FLOURIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [WHOLE FOODS MARKET, INC.]

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365 EVERYDAY VALUE KIDS FLOURIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [WHOLE FOODS MARKET, INC.]
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NDC 42681-5276-9
Set ID 836f2df8-00b6-ff2d-e053-2991aa0a8958
Category HUMAN OTC DRUG LABEL
Packager Whole Foods Market, Inc.
Generic Name
Product Class
Product Number
Application Number PART355
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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

    Tube R3365 EVERYDAY VALUE

    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 ION0.76 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: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 finalpart35503/06/2019
    Labeler - Whole Foods Market, Inc. (196175616)
    Registrant - Lornamead, Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(42681-5276)
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