Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b409c574-67d5-445c-a015-25cf543cb6e4
Route
ORAL
Published
Effective Date 2017-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Water Xylitol Glycerin Zinc Chloride Benzoic Acid Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-01-20
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)

Use
  • Aids in the prevention of dental cavities.
Directions
  • ​Adults and children 6 years of age and older:
  • ​use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 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
  • Store at controlled room temperature 20°-25°C (68°-77°F)
  • Cold weather may cloud this product.
Inactive Ingredients

Water (Aqua), Xylitol, Glycerin, Zinc Chloride, Benzoic Acid, Flavor (Aroma), Methylparaben.

Questions Or Comments?

1-800-632-6900

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

Use
  • Aids in the prevention of dental cavities.
Purpose

Anticavity

Directions
  • ​Adults and children 6 years of age and older:
  • ​use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 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)
  • Store at controlled room temperature 20°-25°C (68°-77°F)
  • Cold weather may cloud this product.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Xylitol, Glycerin, Zinc Chloride, Benzoic Acid, Flavor (Aroma), Methylparaben.

Questions Or Comments? (Questions or Comments?)

1-800-632-6900

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: 2026-02-15T11:56:15.292334 · Updated: 2026-03-14T22:54:36.982637