Label: TOMS WHOLE CARE MOUTHWASH FRESH MINT- sodium fluoride rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 10 mL)

    Sodium fluoride 0.02% (0.01% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Adults and children 6 years of age and older:

    • use twice a day after brushing your teeth with a toothpaste
    • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision

    Children under 6 years of age: consult a dentist or doctor

  • Inactive ingredients

    water, glycerin, sorbitol, Aloe barbadensis leaf juice1, propanediol, xylitol, natural flavor, benzoic acid, phosphoric acid, disodium phosphate

    1
    organic
  • Questions?

    1-800-FOR-TOMS (1-800-367-8667)

  • SPL UNCLASSIFIED SECTION

    © Dist. by TOM'S OF MAINE, INC., KENNEBUNK, ME 04043 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    Certified
    B®
    Corporation

    NEW
    LOOK

    THE ORIGINAL
    Tom's
    OF MAINE

    NATURAL • WITH FLUORIDE
    WHOLE CARE®
    anticavity mouthwash

    6 • BENEFITS FOR HEALTHY TEETH

    6 BENEFITS

    • fights cavities
    • freshens breath
    • restores minerals
    • strengthens enamel
    • cleans between teeth
    • alcohol-free

    FRESH MINT

    16 FL OZ (473 mL)

    IMPORTANT: Read
    directions for proper use

    PS0022908

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TOMS WHOLE CARE MOUTHWASH FRESH MINT 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-837
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SORBITOL (UNII: 506T60A25R)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-837-52473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02112/08/2017
    Labeler - Tom's of Maine, Inc. (052764354)
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