309366f8-6a52-fe9f-e063-6394a90a5de3
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
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
Section 55106-9
Active ingredient
Sodium Fluoride 0.243%
(0.14 w/v fluoride ion)
Structured Label Content
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.
Warnings and Precautions (34071-1)
Warnings
When using this product
- Do not swallow
- Do not use in eye area
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
Section 55106-9 (55106-9)
Active ingredient
Sodium Fluoride 0.243%
(0.14 w/v fluoride ion)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:12.276343 · Updated: 2026-03-14T23:08:50.768383