gurunanda anti-cavity oral rinse

gurunanda anti-cavity oral rinse
SPL v6
SPL
SPL Set ID 3b07b72f-4efc-eb0f-e063-6294a90a70a8
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
glycerin sodium benzoate disodium phosphate xylitol sodium chlorite edetate disodium peg-40 hydrogenated castor oil citric acid stevia leaf levomenthol water sodium bicarbonate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-01

Purpose

Anticavity

Description

Sodium Fluoride 0.05% (0.2 w/v fluoride ion)


Medication Information

Warnings

Warnings

Uses

Aids in the prevention of dental cavities

Purpose

Anticavity

Directions

Adults and children 12 years of age and older:

  • Use once a day after brushing your teeth with a toothpaste.
  • Vigorously swish 10 mL 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 brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until they are capable of using without supervison.

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, Glycerin, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Sodium Bicarbonate, Disodium Phosphate, Sodium Chlorite, Menthol, Stevia Leaf Extract, Flavor, Disodium EDTA, Xylitol, Citric Acid

Description

Sodium Fluoride 0.05% (0.2 w/v fluoride ion)

Section 51945-4

Active Ingredient

Sodium Fluoride 0.05% (0.2 w/v fluoride ion)

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

Uses

Aids in the prevention of dental cavities

Purpose

Anticavity

Directions

Adults and children 12 years of age and older:

  • Use once a day after brushing your teeth with a toothpaste.
  • Vigorously swish 10 mL 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 brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until they are capable of using without supervison.

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, Glycerin, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Sodium Bicarbonate, Disodium Phosphate, Sodium Chlorite, Menthol, Stevia Leaf Extract, Flavor, Disodium EDTA, Xylitol, Citric Acid

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Sodium Fluoride 0.05% (0.2 w/v fluoride ion)

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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