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Simply White

Tom's of Maine, Inc.

Tom's OF MAINE SIMPLY WHITE® fluoride toothpaste clean mint


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 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)

Simply White

Simply White

Sodium fluoride PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-248
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.00243 g

Inactive Ingredients

Ingredient Name Strength
sorbitol
water
HYDRATED SILICA
GLYCERIN
Xylitol
SODIUM LAURYL SULFATE
MENTHOL
XANTHAN GUM
PEPPERMINT OIL
CARRAGEENAN
titanium dioxide
SODIUM HYDROXIDE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 133 in 1 TUBE
2 NDC:51009-248-47 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-08-29


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Be sure to consult your doctor before taking any medication!
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