NATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH- sodium fluoride paste, dentifrice

Natural Fluoride Fresh Mint by

Drug Labeling and Warnings

Natural Fluoride 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]

SPL UNCLASSIFIED SECTION

Drug 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

hydrated silica, water, sorbitol, glycerin, xylitol, sodium lauryl sulfate, natural flavor1, xanthan gum, titanium dioxide, carrageenan.

1 Peppermint oil and other natural flavor

Questions?

1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5 p.m. ET

PRINCIPAL DISPLAY PANEL - 85 g Tube

SINCE 1970
Tom's®
OF MAINE

natural
fluoride
TOOTHPASTE
cavity protection | whitening | fresh breath

fresh mint

NET WT 3 OZ (85 g)

INGREDIENTS AND APPEARANCE

NATURAL FLUORIDE FRESH MINT   CAVITY PROTECTION WHITENING FRESH BREATH
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-238
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O)	Sodium fluoride	0.00243 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Xylitol (UNII: VCQ006KQ1E)
Sodium lauryl sulfate (UNII: 368GB5141J)
Peppermint oil (UNII: AV092KU4JH)
Xanthan gum (UNII: TTV12P4NEE)
Titanium dioxide (UNII: 15FIX9V2JP)
Carrageenan (UNII: 5C69YCD2YJ)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT (Fresh Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-238-59	85 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	09/01/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-238)