SPL v1
SPL
SPL Set ID 2e85d6f7-2df8-4eb9-bc97-d7b7af7fb460
Route
ORAL
Published
Effective Date 2026-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.243 g)
Inactive Ingredients
Water Glycerin Sorbitol Xylitol Hydrated Silica Calcium Carbonate Sodium Bicarbonate Sodium Cocoyl Glutamate Calcium Glycerophosphate Cocos Nucifera (coconut) Oil Potassium Chloride Sodium Benzoate Zinc Citrate Cranberry Juice Green Tea Leaf Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01

Description

Sodium Fluoride 0.243%

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.243%

Uses

Aids in the prevention of dental cavities.

Section 50565-1

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing

is accidentally swallowed, get medical help or contact a Poison Control Central right away.

Directions

Adults and children 2 years and older:

Apply a pea-sized amount of toothpaste. When using an autobrush, split the pea-sized amount evenly across both sides of the brush head. Brush for 30 seconds using a side-to-side or figure-8 motion. With a manual or electric toothbrush, brush thoroughly for 2 minutes.

Children under 6:

Supervise brushing to teach good brushing habits and minimize swallowing.

Children under 2:

Consult a dentist or physician.

Product Label

Active Ingredient

Sodium Fluoride 0.243%

Inactive Ingredients

Water, Glycerin, Sorbitol, Xylitol, Hydrated Silica, Calcium Carbonate, Sodium Bicarbonate (Baking Soda), Sodium Cocoyl Glutamate (from Coconut), Cocos Nucifera (Coconut) Oil, Zinc Citrate, Natural Bubblegum Flavor, Cranberry Extract, Green Tea Extract, Aloe Vera, Potassium Chloride, Calcium Glycerophosphate, Sodium Benzoate.


Structured Label Content

Uses

Aids in the prevention of dental cavities.

Section 50565-1 (50565-1)

Purpose

Anticavity

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing

is accidentally swallowed, get medical help or contact a Poison Control Central right away.

Directions

Adults and children 2 years and older:

Apply a pea-sized amount of toothpaste. When using an autobrush, split the pea-sized amount evenly across both sides of the brush head. Brush for 30 seconds using a side-to-side or figure-8 motion. With a manual or electric toothbrush, brush thoroughly for 2 minutes.

Children under 6:

Supervise brushing to teach good brushing habits and minimize swallowing.

Children under 2:

Consult a dentist or physician.

Product Label (Product label)

Active Ingredient

Sodium Fluoride 0.243%

Inactive Ingredients

Water, Glycerin, Sorbitol, Xylitol, Hydrated Silica, Calcium Carbonate, Sodium Bicarbonate (Baking Soda), Sodium Cocoyl Glutamate (from Coconut), Cocos Nucifera (Coconut) Oil, Zinc Citrate, Natural Bubblegum Flavor, Cranberry Extract, Green Tea Extract, Aloe Vera, Potassium Chloride, Calcium Glycerophosphate, Sodium Benzoate.


Advanced Ingredient Data


Raw Label Data

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