WICKED COOL FLUORIDE TWEEN MILD MINT LMFT- sodium monofluorophosphate paste, dentifrice

Wicked Cool Fluoride Tween Mild Mint LMFT by

Drug Labeling and Warnings

Wicked Cool Fluoride Tween Mild Mint LMFT by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine. 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, carrageenan, sodium lauryl sulfate, natural flavor1

1 peppermint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Label

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 4.2 OZ (119 g)

INGREDIENTS AND APPEARANCE

WICKED COOL FLUORIDE TWEEN MILD MINT LMFT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-812
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride ion - UNII:Q80VPU408O)	Fluoride ion	0.00243 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Calcium Carbonate (UNII: H0G9379FGK)
hydrated silica (UNII: Y6O7T4G8P9)
carrageenan (UNII: 5C69YCD2YJ)
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: 51009-812-42	119 g in 1 TUBE; Type 0: Not a Combination Product	10/19/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	10/19/2012

Labeler - Tom's of Maine (052764354)