Made By Dentist For Kids Chew Toy (bubblegum) Toothpaste

Made By Dentist For Kids Chew Toy (bubblegum) Toothpaste
SPL v2
SPL
SPL Set ID 9bf15cd9-c473-43a5-bbff-507f66a17a56
Route
DENTAL
Published
Effective Date 2025-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Glycerin Water Hydrated Silica Cellulose Gum Cocamidopropyl Betaine Titanium Dioxide Sodium Saccharin Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-01
Description

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity 

Medication Information

Purpose

Anticavity 

Description

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Use:

Aids in the prevention of cavitites.

Section 51945-4

Warnings:

Drug Facts

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 doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.
Package Labeling:

Active Ingredient:

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients:

Glycerin, Water (Aqua), Hydrated Silica, Cellulose Gum, Cocamidopropyl Betaine, Titanium Dioxide, Flavor, Sodium Saccharin, Potassium Sorbate

Questions Or Comments?

+ 1 (646) 980-6461

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

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

Structured Label Content

Use:

Aids in the prevention of cavitites.

Section 51945-4 (51945-4)

Purpose

Anticavity 

Warnings:

Drug Facts

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 doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.
Package Labeling:

Active Ingredient: (Active ingredient:)

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients: (Inactive ingredients:)

Glycerin, Water (Aqua), Hydrated Silica, Cellulose Gum, Cocamidopropyl Betaine, Titanium Dioxide, Flavor, Sodium Saccharin, Potassium Sorbate

Questions Or Comments? (Questions or comments?)

+ 1 (646) 980-6461

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 accidently swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:36.191317 · Updated: 2026-03-14T23:07:39.601528