TOMS CHILDRENS ANTICAVITY FLUORIDE- sodium fluoride gel, dentifrice

Toms Childrens by

Drug Labeling and Warnings

Toms Childrens 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% (0.14% 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

glycerin, water, sorbitol, hydrated silica, propanediol, xylitol, benzyl alcohol, sodium lauryl sulfate, xanthan gum, natural flavor, carrageenan, Stevia rebaudiana extract.

Questions?

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Label

New!

SINCE 1970
Tom's
OF MAINE

natural

children's
gel
anticavity
fluoride toothpaste

fights cavities
contains xylitol
dye free
clear gel

Fruitilicious™

NET WT 4.2 OZ (119 g)

INGREDIENTS AND APPEARANCE

TOMS CHILDRENS   ANTICAVITY FLUORIDE
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-221
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.00243 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PROPANEDIOL (UNII: 5965N8W85T)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-221-42	119 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2017
2	NDC: 51009-221-51	144 g in 1 TUBE; Type 0: Not a Combination Product	12/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/15/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-221)