Hismile Pink Lemonade Sodium Fluoride Anticavity Toothpaste

SPL v2

SPL

SPL Set ID 2b92ff92-3722-3702-e063-6394a90a38b0

Route

ORAL

Published

Effective Date 2025-01-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.243 g)

Inactive Ingredients

Water Sorbitol Xylitol Lauryl Glucoside Sodium Phosphate Xanthan Gum Cellulose Gum Potassium Pyrophosphate 1,2-hexanediol Methyl Diisopropyl Propionamide Sodium Gluconate Zinc Lactate Glycerin D&c Red No. 33 Sodium Lauroyl Sarcosinate Hydrated Silica Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-13

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

Lauryl Glucoside

Sodium Phosphate

Xanthan Gum

Cellulose Gum

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

D&C Red No.33

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 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 (Active ingredient)

sodium fluoride 0.24%

(0.14 w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Lauryl Glucoside

Sodium Phosphate

Xanthan Gum

Cellulose Gum

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

D&C Red No.33

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 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 Lauryl Glucoside Sodium Phosphate Xanthan Gum Cellulose Gum Sodium Lauroyl Sarcosinate Sucralose Tetrapotassium Pyrophosphate 1,2-Hexanediol Methyl Diisopropyl Propionamide Sodium Gluconate Zinc Lactate D&C Red No.33", "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: 2026-02-15T12:05:42.527750 · Updated: 2026-03-14T23:07:58.892866