WHOLE CARE- sodium monofluorophosphate paste, dentifrice WHOLE CARE- sodium monofluorophosphate paste, dentifrice WHOLE CARE- sodium monofluorophosphate paste, dentifrice WHOLE CARE- sodium monofluorophosphate paste, dentifrice

Whole Care by

Drug Labeling and Warnings

Whole Care by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

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)

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)

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)

INGREDIENTS AND APPEARANCE

WHOLE CARE   CINNAMON CLOVE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O)	Sodium monofluorophosphate	0.0076 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Calcium carbonate (UNII: H0G9379FGK)
Hydrated Silica (UNII: Y6O7T4G8P9)
Xylitol (UNII: VCQ006KQ1E)
Carrageenan (UNII: 5C69YCD2YJ)
Zinc citrate (UNII: K72I3DEX9B)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Cinnamon leaf oil (UNII: S92U8SQ71V)
Clove oil (UNII: 578389D6D0)
Clove stem oil (UNII: 9368YZM9M4)

Product Characteristics
Color	WHITE (off-white)	Score
Shape		Size
Flavor	CINNAMON (Cinnamon-Clove)	Imprint Code
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	02/14/2011

WHOLE CARE   PEPPERMINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-104
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O)	Sodium monofluorophosphate	0.0076 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Calcium carbonate (UNII: H0G9379FGK)
Hydrated Silica (UNII: Y6O7T4G8P9)
Xylitol (UNII: VCQ006KQ1E)
Carrageenan (UNII: 5C69YCD2YJ)
Zinc citrate (UNII: K72I3DEX9B)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Peppermint Oil (UNII: AV092KU4JH)

Product Characteristics
Color	WHITE (off-white)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	02/14/2011

WHOLE CARE   SPEARMINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-105
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O)	Sodium monofluorophosphate	0.0076 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Calcium carbonate (UNII: H0G9379FGK)
Hydrated Silica (UNII: Y6O7T4G8P9)
Xylitol (UNII: VCQ006KQ1E)
Carrageenan (UNII: 5C69YCD2YJ)
Zinc citrate (UNII: K72I3DEX9B)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Spearmint Oil (UNII: C3M81465G5)
Peppermint Oil (UNII: AV092KU4JH)

Product Characteristics
Color	WHITE (off-white)	Score
Shape		Size
Flavor	SPEARMINT (Spearmint Ice)	Imprint Code
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	02/14/2011

WHOLE CARE   WINTERMINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-106
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O)	Sodium monofluorophosphate	0.0076 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Calcium carbonate (UNII: H0G9379FGK)
Hydrated Silica (UNII: Y6O7T4G8P9)
Xylitol (UNII: VCQ006KQ1E)
Carrageenan (UNII: 5C69YCD2YJ)
Zinc citrate (UNII: K72I3DEX9B)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Methyl salicylate (UNII: LAV5U5022Y)
Peppermint Oil (UNII: AV092KU4JH)

Product Characteristics
Color	WHITE (off-white)	Score
Shape		Size
Flavor	MINT (Wintermint)	Imprint Code
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	02/14/2011

Labeler - Tom's of Maine, Inc. (052764354)

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		052764354	MANUFACTURE