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Simply White

Tom's of Maine, Inc.

SIMPLY WHITE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

© 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)

Simply White

Simply White

Sodium fluoride PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-148
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.0024 g

Inactive Ingredients

Ingredient Name Strength
sorbitol
water
SILICON DIOXIDE
GLYCERIN
Xylitol
SODIUM LAURYL SULFATE
MENTHOL
XANTHAN GUM
PEPPERMINT OIL
CARRAGEENAN
spearmint oil
titanium dioxide

Product Characteristics

Color
WHITE

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-02-04


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