SPL v1
SPL
SPL Set ID 97f50fbb-abb7-5424-e053-2a95a90a4dee
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
Water Titanium Dioxide Aloe Vera Leaf Xanthan Gum Potassium Nitrate Xylitol Stevia Rebaudiana Whole Menthol Mint Sodium Lauryl Sulfate Sorbitol Glycerin Cocamidopropyl Betaine Coconut Oil Hydrated Silica

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-11-22

Description

Sodium Fluoride 0.24%

Purpose

Anticavity


Medication Information

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 right away.

Questions

800-957-3409

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.

Indications

Aids in the prevention of dental decay.

Active Ingredient

Sodium Fluoride 0.24%

Keep Out of Reach

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

Inactive Ingredients

Sorbitol, Hydrated Silica, Water (Agua), Glycerin, Xylitol, Sodium Lauryl Sulfate, Flavor, Xanthan Gum,Titanium Dioxide, Stevia Rebaudiana Extract, Aloe Barbadensis Leaf Extract, Cocamidopropyl Betaine, Menthol.

Primary Packaging Label

Packaging Label Carton


Structured Label Content

Purpose

Anticavity

Warnings

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

Questions

800-957-3409

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.

Indications

Aids in the prevention of dental decay.

Active Ingredient

Sodium Fluoride 0.24%

Keep Out of Reach (Keep out of reach)

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

Inactive Ingredients

Sorbitol, Hydrated Silica, Water (Agua), Glycerin, Xylitol, Sodium Lauryl Sulfate, Flavor, Xanthan Gum,Titanium Dioxide, Stevia Rebaudiana Extract, Aloe Barbadensis Leaf Extract, Cocamidopropyl Betaine, Menthol.

Primary Packaging Label

Packaging Label Carton (Packaging Label - Carton)


Advanced Ingredient Data


Raw Label Data

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