SIMPLY WHITE SWEET MINT- sodium fluoride paste, dentifrice

Simply White by

Drug Labeling and Warnings

Simply White 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 the 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 flavors, xanthan gum, Chondrus crispus (carrageenan).

Questions?

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

PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton

new!

SINCE 1970
Tom's
OF MAINE™

natural

SIMPLY WHITE®

whitening | cavity protection | fresh breath

fluoride toothpaste

sweet mint gel

NET WT 133.2g (4.7 OZ)

INGREDIENTS AND APPEARANCE

SIMPLY WHITE   SWEET MINT
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-149
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O)	Sodium fluoride	0.0024 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Glycerin (UNII: PDC6A3C0OX)
Xylitol (UNII: VCQ006KQ1E)
Sodium lauryl sulfate (UNII: 368GB5141J)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
Xanthan gum (UNII: TTV12P4NEE)
Peppermint oil (UNII: AV092KU4JH)
Carrageenan (UNII: 5C69YCD2YJ)
Anise (UNII: 21C2F5E8RE)
Vanillin (UNII: CHI530446X)
Clove Oil (UNII: 578389D6D0)
Zingerone (UNII: 4MMW850892)
Piperonal (UNII: KE109YAK00)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-149-06	1 in 1 CARTON	03/12/2010
1		133.2 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 FINAL	part355	03/12/2010

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-149)