SPL v2
SPL
SPL Set ID a3e989f8-e6a2-4e13-8faa-77e95895166d
Route
ORAL
Published
Effective Date 2024-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.03 g)
Inactive Ingredients
Water Sorbitol Glycerin Xylitol Potassium Sorbate Sodium Benzoate Polyoxyl 40 Hydrogenated Castor Oil Saccharin Sodium Cetylpyridinium Chloride Sucralose Citric Acid Monohydrate Methyl Diisopropyl Propionamide D&c Red No. 33 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-10
Description

SODIUM FLUORIDE 0.03%

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

SODIUM FLUORIDE 0.03%

Uses

helps protect teeth against cavities

Warnings

Keep out of reach of children under 6 years of age. lf you accidentally swallow more than used for rinsing, seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children 6 years and older:

  • Use daily after you brush your teeth with toothpaste
  • Rinse toothpaste from mouth prior to use.
  • Shake well before each use.Twist and remove cap.
  • Rinse or gargle for 30 seconds with 15 ml and spit out.
  • Do Notswallow the rinse.
  • Do Noteat or drink for 30 minutes after rinsing
  • Supervise children as necessary.
  • Children under 6 years of age, consult with a dentist or doctor.
Product Label

Active Ingredient

SODIUM FLUORIDE 0.03%

Inactive Ingredients

Water, SORBITOL, GLYCERIN, XYLITOL, POTASSIUM SORBATE, SODIUM BENZOATE, PEG-40 HYDROGENATED CASTOR OIL, FLAVOR

SODIUM FLUORIDE, SODIUM SACCHARIN, CETYLPYRIDINIUM CHLORIDE, SUCRALOSE, CITRIC ACID, METHYL DIISOPROPYL PROPIONAMIDE

D&C Red No.33（CI 17200, FD&C RED NO. 40

Questions Or Comments?

Call toll free 1-877-274-8358

Structured Label Content

Uses

helps protect teeth against cavities

Purpose

Anticavity

Warnings

Keep out of reach of children under 6 years of age. lf you accidentally swallow more than used for rinsing, seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children 6 years and older:

  • Use daily after you brush your teeth with toothpaste
  • Rinse toothpaste from mouth prior to use.
  • Shake well before each use.Twist and remove cap.
  • Rinse or gargle for 30 seconds with 15 ml and spit out.
  • Do Notswallow the rinse.
  • Do Noteat or drink for 30 minutes after rinsing
  • Supervise children as necessary.
  • Children under 6 years of age, consult with a dentist or doctor.
Product Label (Product label)

Active Ingredient (Active ingredient)

SODIUM FLUORIDE 0.03%

Inactive Ingredients (Inactive ingredients)

Water, SORBITOL, GLYCERIN, XYLITOL, POTASSIUM SORBATE, SODIUM BENZOATE, PEG-40 HYDROGENATED CASTOR OIL, FLAVOR

SODIUM FLUORIDE, SODIUM SACCHARIN, CETYLPYRIDINIUM CHLORIDE, SUCRALOSE, CITRIC ACID, METHYL DIISOPROPYL PROPIONAMIDE

D&C Red No.33（CI 17200, FD&C RED NO. 40

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-274-8358

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.162315 · Updated: 2026-03-14T23:13:02.501548