WHOLE CARE ORANGE MANGO- sodium fluoride paste, dentifrice WHOLE CARE SPEARMINT- sodium fluoride paste, dentifrice WHOLE CARE PEPPERMINT- sodium fluoride 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 fluoride 0.24% (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

sorbitol, hydrated silica, water, glycerin, Citrus aurantium dulcis (orange) peel oil and other natural flavors, xylitol, sodium lauryl sulfate, zinc citrate, xanthan gum.

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

orange mango gel

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 gel

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 gel

NET WT 4.7 OZ (133 g)

INGREDIENTS AND APPEARANCE

WHOLE CARE   ORANGE MANGO
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-119
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O)	Sodium fluoride	0.00243 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Sodium lauryl sulfate (UNII: 368GB5141J)
Zinc citrate (UNII: K72I3DEX9B)
Xanthan gum (UNII: TTV12P4NEE)
Mango (UNII: I629I3NR86)
Orange Oil (UNII: AKN3KSD11B)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE, MANGO (Fruity)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-119-47	1 in 1 CARTON	02/14/2011
1		133 g in 1 TUBE; Type 0: Not a Combination Product

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 fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-153
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O)	Sodium fluoride	0.00243 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Sodium lauryl sulfate (UNII: 368GB5141J)
Zinc citrate (UNII: K72I3DEX9B)
Xanthan gum (UNII: TTV12P4NEE)
Spearmint Oil (UNII: C3M81465G5)
Peppermint oil (UNII: AV092KU4JH)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-153-47	1 in 1 CARTON	02/14/2011
1		133 g in 1 TUBE; Type 0: Not a Combination Product

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 fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-158
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O)	Sodium fluoride	0.00243 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Sodium lauryl sulfate (UNII: 368GB5141J)
Zinc citrate (UNII: K72I3DEX9B)
Xanthan gum (UNII: TTV12P4NEE)
Peppermint oil (UNII: AV092KU4JH)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-158-47	1 in 1 CARTON	02/14/2011
1		133 g in 1 TUBE; Type 0: Not a Combination Product

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.		829517189	MANUFACTURE(51009-119, 51009-153, 51009-158)