Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 12bf15ed-bc57-48bc-ba02-b8518a77425b
Route
ORAL
Published
Effective Date 2019-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Sodium Lauryl Sulfate Eucalyptol Methyl Salicylate Thymol Phosphoric Acid Sucralose Menthol Sodium Phosphate Dibasic Dihydrate Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-10-21
Description

Sodium Fluoride 0.02% (0.01% w/v Fluoride ion)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.02% (0.01% w/v Fluoride ion)

Uses

aids in the prevention of dental cavities or decay

Warnings

Directions
  • Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste. Vigorously swish 10 mL of rinse between your teeth for 1 minute then spit out. Do not swallow the rinse. Do not eat or dring for 30 mins after rinsing.
  • Instruct children 12 years of age in good rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.
Label Copy

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v Fluoride ion)

Other Information
  • Cold weather may cloud this product, but will not affect its anticavity properties.
  • Store at room temperature.
Inactive Ingredients

Water (Aqua), Alcohol (21.6%), Sorbitol, Poloxamer 407, Sodium Lauryl Sulfate, Eucalyptol, Flavor, Methyl Salicylate, Thymol, Phosphoric Acid, Sucralose, Menthol, Disodium Phosphate, Red 40 (CI 16035), Blue 1 (CI 42090).

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Uses

aids in the prevention of dental cavities or decay

Purpose

Anticavity

Warnings

Directions
  • Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste. Vigorously swish 10 mL of rinse between your teeth for 1 minute then spit out. Do not swallow the rinse. Do not eat or dring for 30 mins after rinsing.
  • Instruct children 12 years of age in good rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.
Label Copy (Label copy)

Active Ingredient (Active ingredient)

Sodium Fluoride 0.02% (0.01% w/v Fluoride ion)

Other Information (Other information)
  • Cold weather may cloud this product, but will not affect its anticavity properties.
  • Store at room temperature.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Alcohol (21.6%), Sorbitol, Poloxamer 407, Sodium Lauryl Sulfate, Eucalyptol, Flavor, Methyl Salicylate, Thymol, Phosphoric Acid, Sucralose, Menthol, Disodium Phosphate, Red 40 (CI 16035), Blue 1 (CI 42090).

Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:54.948222 · Updated: 2026-03-14T22:55:42.107827