SPL v1
SPL
SPL Set ID 268a5cc3-b688-490d-b64c-9cb51fe7560d
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
Water Sorbitol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Sodium Lauryl Sulfate Sodium Hydroxide Sodium Saccharin Sodium Benzoate Edetate Disodium Menthol

Identifiers & Packaging

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

Sodium Fluoride 0.22 % ( 0.1 % W/V Fluoride Ion)

Purpose

Anticavity Toothpaste

Medication Information

Purpose

Anticavity Toothpaste

Description

Sodium Fluoride 0.22 % ( 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 Fluoride 0.22 % ( 0.1 % W/V Fluoride Ion)

Inactive Ingredients

Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Sodium Hydroxide, Flavor, Sodium saccharin, Sodium Benzoate, Disodium EDTA, Menthol

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 Fluoride 0.22 % ( 0.1 % W/V Fluoride Ion)

Inactive Ingredients (Inactive ingredients)

Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Sodium Hydroxide, Flavor, Sodium saccharin, Sodium Benzoate, Disodium EDTA, Menthol

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:51.471655 · Updated: 2026-03-14T23:09:51.959406