936893e2-518e-5139-e053-2a95a90a076c

SPL v1
SPL
SPL Set ID 936893e2-518e-5139-e053-2a95a90a076c
Route
oral
Published
Effective Date 2019-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (2.4 mg)
Inactive Ingredients
glycerin hydrated silica water xylitol sodium lauryl sulfate mint titanium dioxide xanthan gum stevia rebaudiuna leaf carrageenan sorbitol menthol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph final active Since 2019-09-25
Indications and Usage

Aids in the prevention of dental cavities.

Purpose

Anticavity.

Description

Sodium Fluoride 0.24%

Medication Information

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immedieately.

Indications and Usage

Aids in the prevention of dental cavities.

Purpose

Anticavity.

Directions

- Adults and children 2 years of age and older. Brush teeth thoroughly, preferably after each meal or at least twice a day, or 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.

Inactive Ingredients

Sorbitol, Hydrated Silica, Water (Agua), Glycerin, Xylitol, Sodium Lauryl Sulfate, Flavor, Xanthan Gum,Titanium Dioxide, Menthol, Stevia Rebaudiana Extract, Carrageenan.

Description

Sodium Fluoride 0.24%

Questions?

800-957-3409

Active Ingredient

Sodium Fluoride 0.24%

Principle Package Label

Primary Packaging Carton

Indications and Usage Section

Aids in the prevention of dental cavities.

Keep Out of Reach of Children

Keep out of reach of children under 6 year of age.

Structured Label Content

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immedieately.

Purpose

Anticavity.

Directions

- Adults and children 2 years of age and older. Brush teeth thoroughly, preferably after each meal or at least twice a day, or 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.

Inactive Ingredients

Sorbitol, Hydrated Silica, Water (Agua), Glycerin, Xylitol, Sodium Lauryl Sulfate, Flavor, Xanthan Gum,Titanium Dioxide, Menthol, Stevia Rebaudiana Extract, Carrageenan.

Questions?

800-957-3409

Active Ingredient

Sodium Fluoride 0.24%

Principle Package Label (Principle package label)

Primary Packaging Carton (Primary Packaging - Carton)

Indications and Usage Section

Aids in the prevention of dental cavities.

Keep Out of Reach of Children (Keep out of Reach of Children)

Keep out of reach of children under 6 year of age.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:56.418594 · Updated: 2026-03-14T22:55:43.865902