3f4c6086-b96d-8fa4-e063-6294a90ad800
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Sodium Fluoride
Medication Information
Warnings and Precautions
For oral use only
Keep out of reach of children under 6 years of age.
Do not use in children under 6 years of age unless directed by a dentist or physician.
Avoid contact with eyes and skin. If contact occurs, rinse thoroughly with water.
Do not use for deep cavities close to the pulp unless directed by a dentist.
Do not use if the safety seal is broken or missing.
Indications and Usage
Directions
Tray Method:
Rinse mouth and clean teeth before use.
Fill dental tray evenly with gel and place over dental arch.
Leave in place for 5 minutes.
Remove tray, spit out gel, and rinse mouth thoroughly.
Brush Method:
Apply a small amount of gel evenly to teeth using a toothbrush or cotton swab.
Leave on for 3–5 minutes.
Rinse mouth thoroughly.
Dosage and Administration
Sodium fluoride 0.3% (w/w)
Aids in the prevention of dental cavities and helps strengthen tooth enamel.
Description
Sodium Fluoride
Section 50565-1
Keep out of reach of children under 6 years of age.
Section 50567-7
Tray Method:
Rinse mouth and clean teeth before use.
Fill dental tray evenly with gel and place over dental arch.
Leave in place for 5 minutes.
Remove tray, spit out gel, and rinse mouth thoroughly.
Brush Method:
Apply a small amount of gel evenly to teeth using a toothbrush or cotton swab.
Leave on for 3–5 minutes.
Rinse mouth thoroughly.
Section 50569-3
Do not use in children under 6 years of age unless directed by a dentist or physician.
Section 50570-1
Do not use for deep cavities close to the pulp unless directed by a dentist.
Do not use if the safety seal is broken or missing.
Section 51727-6
Carbomer, Glycerin, Potassium Nitrate, Triethanolamine, Purified Water
Section 51945-4
Section 55105-1
Anticavity
Section 55106-9
Sodium Fluoride
Structured Label Content
Indications and Usage (34067-9)
Directions
Tray Method:
Rinse mouth and clean teeth before use.
Fill dental tray evenly with gel and place over dental arch.
Leave in place for 5 minutes.
Remove tray, spit out gel, and rinse mouth thoroughly.
Brush Method:
Apply a small amount of gel evenly to teeth using a toothbrush or cotton swab.
Leave on for 3–5 minutes.
Rinse mouth thoroughly.
Dosage and Administration (34068-7)
Sodium fluoride 0.3% (w/w)
Aids in the prevention of dental cavities and helps strengthen tooth enamel.
Warnings and Precautions (34071-1)
For oral use only
Keep out of reach of children under 6 years of age.
Do not use in children under 6 years of age unless directed by a dentist or physician.
Avoid contact with eyes and skin. If contact occurs, rinse thoroughly with water.
Do not use for deep cavities close to the pulp unless directed by a dentist.
Do not use if the safety seal is broken or missing.
Section 50565-1 (50565-1)
Keep out of reach of children under 6 years of age.
Section 50567-7 (50567-7)
Tray Method:
Rinse mouth and clean teeth before use.
Fill dental tray evenly with gel and place over dental arch.
Leave in place for 5 minutes.
Remove tray, spit out gel, and rinse mouth thoroughly.
Brush Method:
Apply a small amount of gel evenly to teeth using a toothbrush or cotton swab.
Leave on for 3–5 minutes.
Rinse mouth thoroughly.
Section 50569-3 (50569-3)
Do not use in children under 6 years of age unless directed by a dentist or physician.
Section 50570-1 (50570-1)
Do not use for deep cavities close to the pulp unless directed by a dentist.
Do not use if the safety seal is broken or missing.
Section 51727-6 (51727-6)
Carbomer, Glycerin, Potassium Nitrate, Triethanolamine, Purified Water
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Anticavity
Section 55106-9 (55106-9)
Sodium Fluoride
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:38.425602 · Updated: 2026-03-14T23:12:56.390264