gn anticavity mouthwash

gn anticavity mouthwash
SPL v3
SPL
SPL Set ID 3e90d516-3172-3c8d-e063-6294a90a394f
Route
oral
Published
Effective Date 2025-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.2 mg)
Inactive Ingredients
green tea leaf sodium benzoate water menthol peg-40 hydrogenated castor oil cinnamon bark oil tea tree oil citric acid xylitol glycerin disodium phosphate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-01
Purpose

Anticavity

Description

Sodium Fluoride 0.05%

Medication Information

Warnings

Warnings

Purpose

Anticavity

Directions

Adults and children 6 years of age and older

  • Use once a day 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 rinising.
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until they are capable of using it without supervision.

Children under 6 years of age

  • Consult a dentist or doctor
Other Information
  • Do not use if printed seal is broken or missing
  • Recommended storage temperature 59°F-77°F (15°C-25°C)
Inactive Ingredients

Water, Xylitol, Glycerin, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Flavor, Menthol, Disodium Phosphate, Tea Tree Oil, Cinnamon Bark Oil, Citric Acid, Green Tea Extract

Description

Sodium Fluoride 0.05%

Use

Aids in prevention of dental cavities

Section 51945-4

Active Ingredient

Sodium Fluoride 0.05%

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Structured Label Content

Warnings

Warnings

Purpose

Anticavity

Directions

Adults and children 6 years of age and older

  • Use once a day 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 rinising.
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until they are capable of using it without supervision.

Children under 6 years of age

  • Consult a dentist or doctor
Other Information (Other information)
  • Do not use if printed seal is broken or missing
  • Recommended storage temperature 59°F-77°F (15°C-25°C)
Inactive Ingredients (Inactive ingredients)

Water, Xylitol, Glycerin, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Flavor, Menthol, Disodium Phosphate, Tea Tree Oil, Cinnamon Bark Oil, Citric Acid, Green Tea Extract

Use

Aids in prevention of dental cavities

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Sodium Fluoride 0.05%

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 right away (1-800-222-1222).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:17.588554 · Updated: 2026-03-14T23:12:30.242816