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.. 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, Mentha piperita (peppermint) oil and other natural flavors, xanthan gum, titanium dioxide, Chondrus crispus (carrageenan), sodium hydroxide.

Questions?

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

PRINCIPAL DISPLAY PANEL 133 g Carton

SINCE 1970
Tom's
OF MAINE ®

ADA
Accepted
American
Dental
Association ®

clinically proven   |   natural

SIMPLY WHITE®

whitening   |   cavity protection

fluoride toothpaste

clean mint

NET WT 4.7 OZ (133 g)

INGREDIENTS AND APPEARANCE

SIMPLY WHITE  CLEAN MINT
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-248
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)
Menthol, unspecified form (UNII: L7T10EIP3A)
Xanthan gum (UNII: TTV12P4NEE)
Peppermint oil (UNII: AV092KU4JH)
Carrageenan (UNII: 5C69YCD2YJ)
Titanium dioxide (UNII: 15FIX9V2JP)
Sodium hydroxide (UNII: 55X04QC32I)

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: 51009-248-47	1 in 1 CARTON	08/29/2011
1		133 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	08/29/2011

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-248)