Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity Toothpaste

SPL v2

SPL

SPL Set ID 2ba2318e-7a58-7b68-e063-6394a90ae784

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

Sodium Phosphate Sucralose Lauryl Glucoside Sodium Gluconate Hydrated Silica Glycerin Tetrapotassium Pyrophosphate Zinc Lactate Xylitol Water Sorbitol Sodium Lauroyl Sarcosinate 1,2-hexanediol Xanthan Gum Cellulose Gum Methyl Diisopropyl Propionamide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-14

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

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

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

Sodium Phosphate

Xanthan Gum

Cellulose Gum

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Sucralose

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

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 Sodium Phosphate Xanthan Gum Cellulose Gum Sodium Lauroyl Sarcosinate Tetrapotassium Pyrophosphate 1,2-Hexanediol Sucralose Lauryl Glucoside Methyl Diisopropyl Propionamide Sodium Gluconate Zinc Lactate", "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: 2026-02-15T12:05:42.528717 · Updated: 2026-03-14T23:07:58.892866