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Whole Care

Tom's of Maine, Inc.

Tom's OF MAINE WHOLE CARE 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, xylitol, Chondrus crispus (carrageenan), sodium lauryl sulfate, sodium bicarbonate, zinc citrate, Cinnamomum cassia (cinnamon) leaf oil and other natural flavors.

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

WHOLE CARE ®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

cinnamon clove

NET WT 4.7 OZ (133 g)

Whole Care

PRINCIPAL DISPLAY PANEL - 133 g Carton

Since 1970
Tom's
OF MAINE

with fluoride | natural

WHOLE CARE ®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

peppermint

NET WT 4.7 OZ (133 g)

Whole Care

PRINCIPAL DISPLAY PANEL - 133 g Carton

Since 1970
Tom's
OF MAINE

with fluoride | natural

WHOLE CARE ®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

spearmint

NET WT 4.7 OZ (133 g)

Whole Care

PRINCIPAL DISPLAY PANEL - 133 g Carton

Since 1970
Tom's
OF MAINE

with fluoride | natural

WHOLE CARE ®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

wintermint

NET WT 4.7 OZ (133 g)

Whole Care

Whole Care

Sodium monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-100
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
Zinc Citrate
SODIUM LAURYL SULFATE
Cinnamon leaf oil
Clove oil
Clove stem oil

Product Characteristics

Color
WHITE (off-white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 133 in 1 TUBE
2 NDC:51009-100-47 1 in 1 CARTON

Marketing Information

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


Whole Care

Sodium monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-104
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
Zinc Citrate
SODIUM LAURYL SULFATE
PEPPERMINT OIL

Product Characteristics

Color
WHITE (off-white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 133 in 1 TUBE
2 NDC:51009-104-47 1 in 1 CARTON

Marketing Information

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


Whole Care

Sodium monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-105
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
Zinc Citrate
SODIUM LAURYL SULFATE
spearmint oil
PEPPERMINT OIL

Product Characteristics

Color
WHITE (off-white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 133 in 1 TUBE
2 NDC:51009-105-47 1 in 1 CARTON

Marketing Information

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


Whole Care

Sodium monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51009-106
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
Zinc Citrate
SODIUM LAURYL SULFATE
methyl salicylate
PEPPERMINT OIL

Product Characteristics

Color
WHITE (off-white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 133 in 1 TUBE
2 NDC:51009-106-47 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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