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

Description

Sodium Fluoride 0.05%

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.05%

Use

Aids in prevention of dental cavities

Section 51945-4

Warnings

Warnings

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
Active Ingredient

Sodium Fluoride 0.05%

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

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

Use

Aids in prevention of dental cavities

Section 51945-4 (51945-4)

Purpose

Anticavity

Warnings

Warnings

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
Active Ingredient (Active ingredient)

Sodium Fluoride 0.05%

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

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

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