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Childrens

Tom's of Maine, Inc.

Tom's OF MAINE natural children's silly strawberry


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% 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

glycerin, water, calcium carbonate, hydrated silica, natural flavors, Chondrus crispus (carrageenan), sodium lauryl sulfate.

Questions?

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

PRINCIPAL DISPLAY PANEL - 24.7 g Carton

SINCE 1970
Tom's

OF MAINE

natural
children's

prevents cavities, tastes great
fluoride toothpaste

silly strawberry

ADA
Accepted

American
Dental
Association ®

NET WT .87 OZ (24.7 g)

Childrens

Childrens

Sodium Monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-128
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION 0.0076 g

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
water
CALCIUM CARBONATE
HYDRATED SILICA
Strawberry
CARRAGEENAN
SODIUM LAURYL SULFATE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51009-128-42 119 in 1 TUBE
2 24.7 in 1 TUBE
3 113 in 1 TUBE
4 NDC:51009-128-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2010-08-30


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Be sure to consult your doctor before taking any medication!
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