wonka flavor sodium fluoride anticavity toothpaste

SPL v3

SPL

SPL Set ID 1d458ccc-8f1e-f9c8-e063-6294a90a8da4

Route

dental

Published

Effective Date 2024-07-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.243 g)

Inactive Ingredients

ferrous oxide xylitol hydrated silica sodium lauroyl sarcosinate glycerin 1,2-hexanediol carboxymethylcellulose sodium, unspecified form water sorbitol sodium phosphate xanthan gum potassium pyrophosphate sucralose lauryl glucoside sodium gluconate zinc lactate methyl diisopropyl propionamide

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-07-15

Purpose

Anticavity

Description

Sodium Fluoride 0.243% (0.14 w/v fluoride ion)

Medication Information

Warnings

Warnings

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 use as directed by a dentist or doctor.
Instruct children under 6 years of age in good brushing and rinsing habtis ( 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

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Sodium Phosphate

Xanthan Gum

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Cellulose Gum

Sucralose

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

Iron Oxides

Description

Sodium Fluoride 0.243% (0.14 w/v fluoride ion)

Use

Aids in the prevention of dental cavities

Label

Active Ingredient

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

When Using This Product

Do not swallow
Do not use in eye area

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

Warnings

Warnings

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 use as directed by a dentist or doctor.
Instruct children under 6 years of age in good brushing and rinsing habtis ( 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)

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Sodium Phosphate

Xanthan Gum

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Cellulose Gum

Sucralose

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

Iron Oxides

Use

Aids in the prevention of dental cavities

Label (label)

Active Ingredient (Active ingredient)

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

When Using This Product (When using this product)

Do not swallow
Do not use in eye area

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

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Raw Label Data

All Sections (JSON)

{"Use": "Aids in the prevention of dental cavities", "Purpose": "Anticavity", "Warnings": "Warnings", "Directions": "Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habtis ( to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.", "Active ingredient": "Sodium Fluoride 0.243% (0.14 w/v fluoride ion)", "Inactive ingredients": "Water Sorbitol Glycerin Hydrated Silica Xylitol Sodium Phosphate Xanthan Gum Sodium Lauroyl Sarcosinate Tetrapotassium Pyrophosphate 1,2-Hexanediol Cellulose Gum Sucralose Lauryl Glucoside Methyl Diisopropyl Propionamide Sodium Gluconate Zinc Lactate Iron Oxides", "When using this product": "Do not swallow Do not use in eye area", "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: 2026-02-15T12:08:15.699637 · Updated: 2026-03-14T23:12:26.991151