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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, 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)

Simply White

Simply White

Sodium fluoride PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-149
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
water
SILICON DIOXIDE
GLYCERIN
Xylitol
SODIUM LAURYL SULFATE
MENTHOL
XANTHAN GUM
PEPPERMINT OIL
CARRAGEENAN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 133.2 in 1 TUBE
2 NDC:51009-149-06 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2010-03-12


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