WICKED COOL ANTICAVITY - LMFT51 MRT- sodium monofluorophosphate paste, dentifrice

Wicked Cool Anticavity - LMFT51 MRT by

Drug Labeling and Warnings

Wicked Cool Anticavity - LMFT51 MRT 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% (0.14% 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, sodium lauryl sulfate, carrageenan, benzyl alcohol, natural flavor.

Questions?

1-800-FOR-TOMS (1-800-367-8667)

PRINCIPAL DISPLAY PANEL - 144 g Tube Label

20% more!
vs. 4.2oz size

SINCE 1970
Tom's®
OF MAINE

ADA
Accepted
American
Dental
Association ®

natural
Wicked
Cool!®
fluoride
toothpaste

mild mint

made
for kids
8+

fights cavities
strengthens enamel
freshens breath
dye free

NET WT 5.1 OZ (144 g)

INGREDIENTS AND APPEARANCE

WICKED COOL ANTICAVITY - LMFT51 MRT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-912
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.0014 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Carrageenan (UNII: 5C69YCD2YJ)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Hydrated Silica (UNII: Y6O7T4G8P9)
Benzyl Alcohol (UNII: LKG8494WBH)
Calcium Carbonate (UNII: H0G9379FGK)
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: 51009-912-51	144 g in 1 TUBE; Type 0: Not a Combination Product	11/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/15/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-912)