CAVITY PROTECTION- sodium monofluorophosphate paste, dentifrice CAVITY PROTECTION- sodium monofluorophosphate paste, dentifrice

Cavity Protection by

Drug Labeling and Warnings

Cavity Protection 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% (0.15% 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)

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)

INGREDIENTS AND APPEARANCE

CAVITY PROTECTION   PEPPERMINT WITH BAKING SODA
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-120
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
Calcium carbonate (UNII: H0G9379FGK)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Sodium Bicarbonate (UNII: 8MDF5V39QO)
Carrageenan (UNII: 5C69YCD2YJ)
Xylitol (UNII: VCQ006KQ1E)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Peppermint oil (UNII: AV092KU4JH)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

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

CAVITY PROTECTION   SPEARMINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-116
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
Calcium carbonate (UNII: H0G9379FGK)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Carrageenan (UNII: 5C69YCD2YJ)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Spearmint Oil (UNII: C3M81465G5)
Peppermint oil (UNII: AV092KU4JH)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

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