d859d02d-a036-4d90-bed4-9a5c31e9e1ef

SPL v1
SPL
SPL Set ID d859d02d-a036-4d90-bed4-9a5c31e9e1ef
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

Purpose

Anticavity

Description

Sodium Fluoride 0.243%


Medication Information

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.

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity

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.

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 Mint Flavor, Cranberry Extract, Green Tea Extract, Aloe Vera, Potassium Chloride, Calcium Glycerophosphate, Sodium Benzoate.

Description

Sodium Fluoride 0.243%

Section 50565-1

Product Label

Active Ingredient

Sodium Fluoride 0.243%


Structured Label Content

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.

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity

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.

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 Mint Flavor, Cranberry Extract, Green Tea Extract, Aloe Vera, Potassium Chloride, Calcium Glycerophosphate, Sodium Benzoate.

Section 50565-1 (50565-1)

Product Label (Product label)

Active Ingredient

Sodium Fluoride 0.243%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)