Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a271e0ff-614b-4b8b-9eec-de82c8c12e4d
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 Sorbitol Propylene Glycol Poloxamer 407 Sodium Lauryl Sulfate Phosphoric Acid Eucalyptol Methyl Salicylate Thymol Menthol Sodium Phosphate Dibasic Dihydrate Sucralose 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

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 drink for 30 minutes 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), Sorbitol, Propylene Glycol, Poloxamer 407, Sodium Lauryl Sulfate, Flavor, Phosphoric Acid, Eucalyptol, Methyl Salicylate, Thymol, Menthol, Disodium Phosphate, Sucralose, 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

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 drink for 30 minutes 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 (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), Sorbitol, Propylene Glycol, Poloxamer 407, Sodium Lauryl Sulfate, Flavor, Phosphoric Acid, Eucalyptol, Methyl Salicylate, Thymol, Menthol, Disodium Phosphate, Sucralose, 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: 2026-02-15T11:56:54.955731 · Updated: 2026-03-14T22:55:42.107827