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Cavity Protection

Tom's of Maine, Inc.

Tom's OF MAINE CAVITY PROTECTION fluoride toothpaste


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (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

calcium carbonate, water, glycerin, sodium bicarbonate, Chondrus crispus (carrageenan), Mentha piperita (peppermint) oil, xylitol, 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 - 155.9 g Carton

SINCE 1970
Tom's
OF MAINE

baking soda ∣ natural

CAVITY PROTECTION

fights cavities ∣ fresh breath

fluoride toothpaste

peppermint

ADA
Accepted

American
Dental
Association ®

NET WT 5.5 OZ (155.9 g)

Cavity Protection

PRINCIPAL DISPLAY PANEL - 155.9 g Carton

SINCE 1970
Tom's
OF MAINE

natural

CAVITY PROTECTION

fights cavities ∣ fresh breath

fluoride toothpaste

spearmint

ADA
Accepted

American
Dental
Association ®

NET WT 5.5 OZ (155.9 g)

Cavity Protection

Cavity Protection

Sodium Monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-120
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
CALCIUM CARBONATE
GLYCERIN
water
SODIUM BICARBONATE
CARRAGEENAN
Xylitol
SODIUM LAURYL SULFATE
PEPPERMINT OIL

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 155.9 in 1 TUBE
2 NDC:51009-120-55 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-02-14


Cavity Protection

Sodium Monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-116
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
CALCIUM CARBONATE
GLYCERIN
water
Xylitol
CARRAGEENAN
SODIUM LAURYL SULFATE
spearmint oil
PEPPERMINT OIL

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 155.9 in 1 TUBE
2 NDC:51009-116-55 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-02-14


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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