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Clean and Gentle

Tom's of Maine, Inc.

Tom's OF MAINE CLEAN & GENTLE fluoride toothpaste


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, organic Aloe barbadensis (aloe) leaf juice, xylitol, Chondrus crispus (carrageenan), Acacia senegal (acacia) gum, glycyrrhizic acid, Mentha piperita (peppermint) oil.

Questions?

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

PRINCIPAL DISPLAY PANEL - 133 g Carton

SINCE 1970
Tom's
OF MAINE

with fluoride | natural

CLEAN & GENTLE

SLS-free | anticavity | whitening | fresh breath
fluoride toothpaste

peppermint

NET WT 4.7 OZ (133 g)

Clean and Gentle

Clean and Gentle

Sodium Monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-107
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
Xylitol
CARRAGEENAN
PEPPERMINT OIL
Glycyrrhizin
Aloe Vera Leaf

Product Characteristics

Color
WHITE (Off-white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 133 in 1 TUBE
2 NDC:51009-107-47 1 in 1 CARTON

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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