TOMS KIDS WATERMELON WIGGLE- sodium monofluorophosphate paste, dentifrice

Toms Kids Watermelon Wiggle by

Drug Labeling and Warnings

Toms Kids Watermelon Wiggle 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, natural flavor, sodium lauryl sulfate, carrageenan, rebaudioside A, benzyl alcohol.

Questions?

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

PRINCIPAL DISPLAY PANEL - 144 g Tube Label

THE ORIGINAL
Tom's
OF MAINE

Kid's
NATURAL

fluoride
anticavity toothpaste

fights cavities
tastes great dye free

ages
2+

WATERMELON WIGGLE

NET WT
5.1 OZ
(144 g)

BRUSH
RECYCLE*
SMILE

INGREDIENTS AND APPEARANCE

TOMS KIDS WATERMELON WIGGLE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-854
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  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)
BENZYL ALCOHOL (UNII: LKG8494WBH)
REBAUDIOSIDE A (UNII: B3FUD0528F)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-854-42	119 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2023	12/30/2025
2	NDC: 51009-854-51	144 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	12/01/2023

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