Candy Cane Flavor Sodium Fluoride Anticavity Toothpaste

SPL v2

SPL

SPL Set ID 1e725b7e-accc-f51c-e063-6394a90a455c

Route

DENTAL

Published

Effective Date 2024-07-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.243 g)

Inactive Ingredients

Carboxymethylcellulose Sodium, Unspecified Form Xylitol Hydrated Silica Sodium Lauroyl Sarcosinate Glycerin Caprylyl Glycol Water Sorbitol Xanthan Gum Sucralose Sodium Gluconate Zinc Lactate Methyl Diisopropyl Propionamide Pentylene Glycol Benzyl Alcohol Benzoic Acid Sodium Phosphate, Dibasic, Anhydrous Potassium Pyrophosphate Menthol Titanium Dioxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-07-23

Description

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

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

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

Use

Aids in the prevention of dental cavities

Label

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

Hydrated Silica

Glycerin

Xylitol

Disodium Phosphate

Sucralose

Sodium Lauroyl Sarcosinate

Xanthan Gum

Cellulose Gum

Flavor

Tetrapotassium Pyrophosphate

Caprylyl Glycol

Benzyl Alcohol

Menthol

Sodium Gluconate

Pentylene Glycol

Zinc Lactate

Benzoic Acid

Methyl Diisopropyl Propionamide

Titanium Dioxide

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

Use

Aids in the prevention of dental cavities

Label (label)

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 (Active ingredient)

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Water

Sorbitol

Hydrated Silica

Glycerin

Xylitol

Disodium Phosphate

Sucralose

Sodium Lauroyl Sarcosinate

Xanthan Gum

Cellulose Gum

Flavor

Tetrapotassium Pyrophosphate

Caprylyl Glycol

Benzyl Alcohol

Menthol

Sodium Gluconate

Pentylene Glycol

Zinc Lactate

Benzoic Acid

Methyl Diisopropyl Propionamide

Titanium Dioxide

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 Hydrated Silica Glycerin Xylitol Disodium Phosphate Sucralose Sodium Lauroyl Sarcosinate Xanthan Gum Cellulose Gum Flavor Tetrapotassium Pyrophosphate Caprylyl Glycol Benzyl Alcohol Menthol Sodium Gluconate Pentylene Glycol Zinc Lactate Benzoic Acid Methyl Diisopropyl Propionamide Titanium Dioxide", "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: 2026-02-15T12:08:15.701581 · Updated: 2026-03-14T23:12:26.991151