Tom's Kid's Watermelon Wiggle

SPL v2

SPL

SPL Set ID 48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62

Route

DENTAL

Published

Effective Date 2023-09-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.1 mg)

Inactive Ingredients

Glycerin Water Calcium Carbonate Hydrated Silica Carrageenan Sodium Lauryl Sulfate Benzyl Alcohol Rebaudioside A

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2023-12-01 Until 2025-12-30

Description

Drug Facts

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

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

Questions?

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

Active Ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Inactive Ingredients

glycerin, water, calcium carbonate, hydrated silica, natural flavor, sodium lauryl sulfate, carrageenan, rebaudioside A, benzyl alcohol.

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

Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Purpose

Anticavity

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

Questions?

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

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

glycerin, water, calcium carbonate, hydrated silica, natural flavor, sodium lauryl sulfate, carrageenan, rebaudioside A, benzyl alcohol.

Principal Display Panel 144 G Tube Label (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

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARRAGEENAN", "unii": "5C69YCD2YJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "REBAUDIOSIDE A", "unii": "B3FUD0528F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "helps protect against cavities", "42229-5": "Drug Facts", "50565-1": "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).", "Purpose": "Anticavity", "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", "Questions?": "1-800-FOR-TOMS (1-800-367-8667)", "Active ingredient": "Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)", "Inactive ingredients": "glycerin, water, calcium carbonate, hydrated silica, natural flavor, sodium lauryl sulfate, carrageenan, rebaudioside A, benzyl alcohol.", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:01.957883 · Updated: 2026-03-14T23:04:26.705807