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Childrens

Tom's of Maine, Inc.

Tom's OF MAINE


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 - 119 g Tube

SINCE 1970
Tom's

OF MAINE

ADA
Accepted

American
Dental
Association ®

natural
children's

prevents
cavities

tastes great

fluoride toothpaste

outrageous
orange mango

NET WT 4.2 OZ (119 g)

Childrens

Childrens

Sodium Monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-127
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
ORANGE
CARRAGEENAN
SODIUM LAURYL SULFATE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113 in 1 TUBE
2 NDC:51009-127-04 1 in 1 CARTON

Marketing Information

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


Childrens

Sodium Monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-830
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
ORANGE
CARRAGEENAN
SODIUM LAURYL SULFATE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51009-830-94 119 in 1 TUBE

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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