Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpaste

SPL v2

SPL

SPL Set ID 2b3e72ca-2bbb-adf1-e063-6394a90a2c7a

Route

ORAL

Published

Effective Date 2025-01-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.243 g)

Inactive Ingredients

Sorbitol 1,2-hexanediol Lauryl Glucoside Sodium Gluconate Fd&c Red No. 40 Xylitol Sodium Phosphate Cellulose Gum Tetrapotassium Pyrophosphate Methyl Diisopropyl Propionamide Hydrated Silica Glycerin Xanthan Gum Sucralose Zinc Lactate Fd&c Blue No. 1 Sodium Lauroyl Sarcosinate Water

Identifiers & Packaging

Pill Appearance

Color: red Color: blue

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-09

Description

Sodium fluoride 0.24% (0.14% w/v fluoride ion)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.24% (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 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.

Active Ingredient

Sodium fluoride 0.24%

(0.14% w/v fluoride ion)

Inactive Ingredients

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Sodium Phosphate

Xanthan Gum

Cellulose Gum

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Sucralose

Lauryl Glucoside

Sodium Fluoride

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

FD&C Red No.40

FD&C Blue No.1

When Using This Product

Do not swallow

Do not use in eye area

Keep Out of Reach of Children Under 6 Years

Keep out of reach of children under 6 years. 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 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.

Active Ingredient

Sodium fluoride 0.24%

(0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Sodium Phosphate

Xanthan Gum

Cellulose Gum

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Sucralose

Lauryl Glucoside

Sodium Fluoride

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

FD&C Red No.40

FD&C Blue No.1

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 (Keep out of reach of children under 6 years)

Keep out of reach of children under 6 years. 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 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.", "Active Ingredient": "Sodium fluoride 0.24% (0.14% w/v fluoride ion)", "Inactive ingredients": "Water Sorbitol Glycerin Hydrated Silica Xylitol Sodium Phosphate Xanthan Gum Cellulose Gum Sodium Lauroyl Sarcosinate Tetrapotassium Pyrophosphate 1,2-Hexanediol Sucralose Lauryl Glucoside Sodium Fluoride Methyl Diisopropyl Propionamide Sodium Gluconate Zinc Lactate FD&C Red No.40 FD&C Blue No.1", "When using this product": "Do not swallow Do not use in eye area", "Keep out of reach of children under 6 years": "Keep out of reach of children under 6 years. 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: 2026-02-15T12:05:42.526574 · Updated: 2026-03-14T23:07:58.892866