Label: 365 EVERYDAY VALUE CAVITY FIGHTING AND WHITENING- sodium monoflourophosphate paste, dentifrice

  • NDC Code(s): 42681-5002-1, 42681-5002-9
  • Packager: Whole Foods Market, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 13, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium monofluorophosphate 0.76%

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Uses aids in the prevention of dental caviites

  • 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 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

    Inactive ingredients glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, sodium lauroyl sarcosinate, natural flavor, zinc citrate, benzyl alcohol

  • STORAGE AND HANDLING

    Other information

    Store in a cool dry place. Tamper evident, use only if box seal is intact. Keep tube capped when not in use.

  • QUESTIONS

    Questions or comments?

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

    DISTRIBUTED BY:

    WHOLE FOODS MARKET

    AUSTIN, TX 78703

    www.wholefoodsmarket.com

    MADE IN USA FROM DOMESTIC AND IMPORTED INGREDIENTS

  • Principal Display Panel

    Carton R1365 EVERYDAY VALUE

    PEPPERMINT

    FLUORIDE TOOTHPASTE

    CAVITY FIGHTING & WHITENING

    Helps fight tartar

    Made with Xylitol

    Made without Dyes

    Made without Sodium Lauryl Sulfate or Laureth Sulfate

    NET WT 5.5 OZ (156g)

  • INGREDIENTS AND APPEARANCE
    365 EVERYDAY VALUE  CAVITY FIGHTING AND WHITENING
    sodium monoflourophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42681-5002
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42681-5002-91 in 1 CARTON03/06/2019
    1156 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:42681-5002-11 in 1 CARTON04/15/2024
    285 g in 1 TUBE; Type 0: Not a Combination Product
    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(42681-5002)