SPL v1
SPL
SPL Set ID 85829106-f8fa-41c0-b7dd-6be0fdf857e3
Route
ORAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 g)
Inactive Ingredients
Calcium Carbonate Sorbitol Water Sodium Lauryl Sulfate Silica Glycerin Carboxymethylcellulose Benzalkonium Chloride Sodium Saccharin Polyethylene Glycol 400 Sodium Chloride Methylparaben Sodium Menthol Propylparaben Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Sodium Monofluorophophate 0.76 % ( 0.1 % W/V Fluoride Ion)

Purpose

Anticavity Toothpaste


Medication Information

Purpose

Anticavity Toothpaste

Description

Sodium Monofluorophophate 0.76 % ( 0.1 % W/V Fluoride Ion)

Uses

• Help Protect against cavities

Section 50565-1

Warnings

Keep out of the 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 center immediately

Directions
 Adults & children 6 years of age & older:  Brush teeth thoroughly, Preferably after each meal of at least twice a day, or as directed by a dentist or doctor
 Children 2 to 6 years  Use only pea sized amount and supervise child’s brushing and rinsing (to minimize swallowing).
 Children under 2 years  Ask a dentist or physician

Product Label

Active Ingredient

Sodium Monofluorophophate 0.76 % ( 0.1 % W/V Fluoride Ion)

Inactive Ingredients

Calcium carbonate, Sorbitol, Water, Sodium lauryl Sulfate, Silica, Glycerin, Cellulose Gum, Benzalkonium Chloride, Flavor, Sodium Saccharin, PEG 400, Sodium Chloride, Sodium Methyl paraben, Menthol, Sodium Propyl paraben


Structured Label Content

Uses

• Help Protect against cavities

Section 50565-1 (50565-1)

Purpose

Anticavity Toothpaste

Warnings

Keep out of the 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 center immediately

Directions
 Adults & children 6 years of age & older:  Brush teeth thoroughly, Preferably after each meal of at least twice a day, or as directed by a dentist or doctor
 Children 2 to 6 years  Use only pea sized amount and supervise child’s brushing and rinsing (to minimize swallowing).
 Children under 2 years  Ask a dentist or physician

Product Label (Product label)

Active Ingredient

Sodium Monofluorophophate 0.76 % ( 0.1 % W/V Fluoride Ion)

Inactive Ingredients (Inactive ingredients)

Calcium carbonate, Sorbitol, Water, Sodium lauryl Sulfate, Silica, Glycerin, Cellulose Gum, Benzalkonium Chloride, Flavor, Sodium Saccharin, PEG 400, Sodium Chloride, Sodium Methyl paraben, Menthol, Sodium Propyl paraben


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)