309366f8-6a52-fe9f-e063-6394a90a5de3

SPL v1
SPL
SPL Set ID 309366f8-6a52-fe9f-e063-6394a90a5de3
Route
dental
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.243 g)
Inactive Ingredients
water sodium gluconate sodium lauryl sarcosinate 1,2-hexanediol zinc lactate methyl diisopropyl propionamide titanium dioxide sucralose lauryl glucoside xylitol xanthan gum sorbitol glycerin hydrated silica iron oxides fd&c red no. 40 tetrapotassium pyrophosphate sodium phosphate sodium methyl cocoyl taurate mica cellulose gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-06-01

Description

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


Medication Information

Warnings and Precautions

Warnings

When using this product

  • Do not swallow
  • Do not use in eye area

Active Ingredient

Active ingredient

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

Indications and Usage

Use

Aids in the prevention of dental cavities

Dosage and Administration

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.

Description

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

Section 50565-1

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.

Section 51727-6

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Flavor

Sodium Methyl Cocoyl Taurate

Xanthan Gum

Cellulose Gum

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

Sodium Phosphate

Lauryl Glucoside

Sodium Gluconate

1,2-Hexanediol

Mica

Zinc Lactate

Methyl Diisopropyl Propionamide

Titanium Dioxide

Iron Oxides

FD&C Red No.40

Section 51945-4

Hismile Lucky Charms Magically Delicious Flavor Sodium Fluoride Anticavity Toothpaste Gel

Section 55105-1

Purpose

Anticavity


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

When using this product

  • Do not swallow
  • Do not use in eye area

Active Ingredient (55106-9)

Active ingredient

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

Indications and Usage (34067-9)

Use

Aids in the prevention of dental cavities

Dosage and Administration (34068-7)

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.

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Flavor

Sodium Methyl Cocoyl Taurate

Xanthan Gum

Cellulose Gum

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

Sodium Phosphate

Lauryl Glucoside

Sodium Gluconate

1,2-Hexanediol

Mica

Zinc Lactate

Methyl Diisopropyl Propionamide

Titanium Dioxide

Iron Oxides

FD&C Red No.40

Section 51945-4 (51945-4)

Hismile Lucky Charms Magically Delicious Flavor Sodium Fluoride Anticavity Toothpaste Gel

Section 55105-1 (55105-1)

Purpose

Anticavity


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)