SIMPLY WHITE CLEAN 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., Colgate-Palmolive Canada, 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, titanium dioxide, Chondrus crispus (carrageenan).

Questions?

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

SPL UNCLASSIFIED SECTION

© 2010 Tom's of Maine, Inc., 302 Lafayette Ctr., Kennebunk, ME 04043
Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton

new!

SINCE 1970
Tom's
OF MAINE™

natural

SIMPLY WHITE®
whitening | cavity protection | fresh breath
fluoride toothpaste
clean mint

NET WT 133.2g (4.7 OZ)

INGREDIENTS AND APPEARANCE

SIMPLY WHITE  CLEAN MINT
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-148
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 (UNII: L7T10EIP3A)
Xanthan gum (UNII: TTV12P4NEE)
Peppermint oil (UNII: AV092KU4JH)
Carrageenan (UNII: 5C69YCD2YJ)
Spearmint oil (UNII: C3M81465G5)
Titanium dioxide (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-148-47	1 in 1 CARTON
1		133.2 g in 1 TUBE
2	NDC: 51009-148-01	1 in 1 CARTON
2		25 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	02/04/2011

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		052764354	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive Canada, Inc.		259157246	MANUFACTURE