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

Description

Sodium Fluoride 0.24%

Indications and Usage

Aids in the prevention of dental cavities.

Purpose

Anticavity.


Medication Information

Indications and Usage

Aids in the prevention of dental cavities.

Purpose

Anticavity.

Description

Sodium Fluoride 0.24%

Warnings

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

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.

Questions?

800-957-3409

Active Ingredient

Sodium Fluoride 0.24%

Inactive Ingredients

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

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

Purpose

Anticavity.

Warnings

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

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.

Questions?

800-957-3409

Active Ingredient

Sodium Fluoride 0.24%

Inactive Ingredients

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

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)