firefly® sonic the hedgehog bubble gum natural fluoride toothpaste drug facts

SPL v1

SPL

SPL Set ID 2a882210-49e6-4b9c-a2c6-eaa37b6514c3

Route

dental

Published

Effective Date 2024-11-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.24 g)

Inactive Ingredients

sorbitol water hydrated silica xylitol glycerin xanthan gum lauryl glucoside cocamidopropyl betaine stevia rebaudiuna leaf

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-01-03

Purpose

Anticavity toothpaste

Description

Sodium Fluoride 0.24%

Medication Information

Purpose

Anticavity toothpaste

Directions

•
adults and children 2 years of age and older: brush teeth thoroughly, preferable after each meal or at least twice a day, or as directed by a dentist or doctor
•
instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
•
supervise children as necessary until capable of using without supervision
•
children under 2 years of age: consult a dentist or doctor

Inactive Ingredients

sorbitol, water, hydrated silica, zylitol, glycerin, flavor, xanthan gum, lauryl glucoside, cocamidopropyl betaine, stevia rebaudiana extract

Description

Sodium Fluoride 0.24%

Questions?

Toll Free: 1-866-373-7374

Use

helps protect against cavities

Active Ingredient

Sodium Fluoride 0.24%

Package/label Principal Display Panel

FIREFLY®

BUBBLE GUM natural fluoride toothpaste

98% natural origin

SONIC™ THE HEDGEHOG

FIGHTS CAVITIES

NO artificial flavors

NO artificial colors

ADA Accepted American Dental Association®

NET WT 4.2 oz (119 g)

Keep Out of Reach of Children Under 6 Years of Age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Purpose

Anticavity toothpaste

Directions

•
adults and children 2 years of age and older: brush teeth thoroughly, preferable after each meal or at least twice a day, or as directed by a dentist or doctor
•
instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
•
supervise children as necessary until capable of using without supervision
•
children under 2 years of age: consult a dentist or doctor

Inactive Ingredients (Inactive ingredients)

sorbitol, water, hydrated silica, zylitol, glycerin, flavor, xanthan gum, lauryl glucoside, cocamidopropyl betaine, stevia rebaudiana extract

Questions?

Toll Free: 1-866-373-7374

Use

helps protect against cavities

Active Ingredient (Active ingredient)

Sodium Fluoride 0.24%

Package/label Principal Display Panel (Package/Label Principal Display Panel)

FIREFLY®

BUBBLE GUM natural fluoride toothpaste

98% natural origin

SONIC™ THE HEDGEHOG

FIGHTS CAVITIES

NO artificial flavors

NO artificial colors

ADA Accepted American Dental Association®

NET WT 4.2 oz (119 g)

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.24", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURYL GLUCOSIDE", "unii": "76LN7P7UCU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEVIA REBAUDIUNA LEAF", "unii": "6TC6NN0876", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "helps protect against cavities", "Purpose": "Anticavity toothpaste", "Directions": "• adults and children 2 years of age and older: brush teeth thoroughly, preferable after each meal or at least twice a day, or as directed by a dentist or doctor • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) • supervise children as necessary until capable of using without supervision • children under 2 years of age: consult a dentist or doctor", "Questions?": "Toll Free: 1-866-373-7374", "Active ingredient": "Sodium Fluoride 0.24%", "Inactive ingredients": "sorbitol, water, hydrated silica, zylitol, glycerin, flavor, xanthan gum, lauryl glucoside, cocamidopropyl betaine, stevia rebaudiana extract", "Package/Label Principal Display Panel": "FIREFLY® BUBBLE GUM natural fluoride toothpaste 98% natural origin SONIC™ THE HEDGEHOG FIGHTS CAVITIES NO artificial flavors NO artificial colors ADA Accepted American Dental Association® NET WT 4.2 oz (119 g)", "Keep out of reach of children under 6 years of age.": "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:32.335269 · Updated: 2026-03-14T23:05:21.514130