TOMS OF MAINE DEEP CLEAN SPEARMINT- sodium fluoride paste, dentifrice

Toms of Maine Deep Clean Spearmint by

Drug Labeling and Warnings

Toms of Maine Deep Clean Spearmint by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, COLGATE PALMOLIVE COMPANY, Tom's of Maine, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drugs Facts

Active ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

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 dial (412) 390-3381 right away (Poison Control Center).

Directions

• adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
• children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• children under 2 years: ask a dentist or physician

Inactive ingredients

water, sorbitol, hydrated silica, glycerin, xylitol, lauryl glucoside, disodium cocoyl glutamate, natural flavor1, xanthan gum, tetrasodium pyrophosphate, benzyl alcohol, rebaudioside A, potassium hydroxide.

1 spearmint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

THE ORIGINAL
Tom's
OF MAINE

NOT TESTED ON
ANIMALS

NATURAL WITH FLUORIDE

WHITEN +
DEEP CLEAN

anticavity toothpaste

SPEARMINT

NET WT 4.0 OZ (113 g)

NATURALLY DERIVED
MICRO-POLISHERS

REMOVES 95% OF
SURFACE STAINS*

PREVENTS STAINS†

NO
ANIMAL TESTING, SLS,
PEROXIDE, ARTIFICIAL
FLAVORS OR DYES

INGREDIENTS AND APPEARANCE

TOMS OF MAINE DEEP CLEAN SPEARMINT 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-921
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)
SPEARMINT OIL (UNII: C3M81465G5)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
REBAUDIOSIDE A (UNII: B3FUD0528F)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-921-40	1 in 1 CARTON	01/01/2025
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	01/01/2025

Labeler - Tom's of Maine (052764354)

Registrant - COLGATE PALMOLIVE COMPANY (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	ANALYSIS(51009-921) , MANUFACTURE(51009-921) , PACK(51009-921) , LABEL(51009-921)