TOMS WHOLE CARE MOUTHWASH FRESH MINT- sodium fluoride rinse

Toms Whole Care Mouthwash Fresh Mint by

Drug Labeling and Warnings

Toms Whole Care Mouthwash Fresh Mint by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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)

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

SINCE 1970
Tom's®
OF MAINE

fluoride mouthwash | natural

WHOLE CARE®

6 BENEFITS

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

fresh mint

16 FL OZ (473 mL)

P9937076
IMPORTANT: Read
directions for proper use

INGREDIENTS AND APPEARANCE

TOMS WHOLE CARE MOUTHWASH FRESH MINT 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-837
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-837-52	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/08/2017

Labeler - Tom's of Maine, Inc. (052764354)

Registrant - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(51009-837)