SPL v2
SPL
SPL Set ID fd27af7b-6f61-aa84-e053-6294a90aae0a
Route
ORAL
Published
Effective Date 2018-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.24 g)
Inactive Ingredients
Glycerin Water Hydrated Silica Sodium Laurylglucosides Hydroxypropylsulfonate Titanium Dioxide Peppermint Oil Carrageenan Anhydrous Citric Acid Stevia Rebaudiuna Leaf Menthol, (+)- Sodium Chloride Xanthan Gum Sodium Benzoate Sodium Bicarbonate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-01
Description

Sodium Fluoride 0.24%

Medication Information

Warnings and Precautions

Avoid storing at high temperatures (greater than 100°F). Protect from freezing. If you accidentally swalow more than used for brushing, seek professional assistance or contact Poison Control immediately.

Indications and Usage





use: Prevention of cavities

Dosage and Administration

Prevent plaque and tartar buildup with regular brushing. Adults and children 2 years of age or older should brush teeth after each meal (or at least twice a day, or as directed by a dentist or doctor). Children under 6: To minimize swallowing, use a pea sized amount of paste and supervise rushing until good habits are established. Children under 2, check with a dentist or physician before using.

Description

Sodium Fluoride 0.24%

Section 50565-1

Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact Poison Control Center immediately.

Section 51727-6

Glycerin, Water (Aqua), Hydrated Silica, Sodium Laurylglucosides Hydroxypropylsulfonate, Titanium Dioxide, Mentha Piperita (Peppermint) Oil, Chondrus Crispus (Carrageenan), Stevia Rebaudiana Leaf/Stem Extract, Citric Acid, Menthol, Sodium Bicarbonate, Sodium Chloride, Xanthan Gum, Sodium Benzoate

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9





Sodium Fluoride 0.24%

Structured Label Content

Indications and Usage (34067-9)





use: Prevention of cavities

Dosage and Administration (34068-7)

Prevent plaque and tartar buildup with regular brushing. Adults and children 2 years of age or older should brush teeth after each meal (or at least twice a day, or as directed by a dentist or doctor). Children under 6: To minimize swallowing, use a pea sized amount of paste and supervise rushing until good habits are established. Children under 2, check with a dentist or physician before using.

Warnings and Precautions (34071-1)

Avoid storing at high temperatures (greater than 100°F). Protect from freezing. If you accidentally swalow more than used for brushing, seek professional assistance or contact Poison Control immediately.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact Poison Control Center immediately.

Section 51727-6 (51727-6)

Glycerin, Water (Aqua), Hydrated Silica, Sodium Laurylglucosides Hydroxypropylsulfonate, Titanium Dioxide, Mentha Piperita (Peppermint) Oil, Chondrus Crispus (Carrageenan), Stevia Rebaudiana Leaf/Stem Extract, Citric Acid, Menthol, Sodium Bicarbonate, Sodium Chloride, Xanthan Gum, Sodium Benzoate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)





Sodium Fluoride 0.24%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:34.308288 · Updated: 2026-03-14T23:05:25.370894