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
Description

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

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

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

Uses

Aids in the prevention of dental cavities

Section 51945-4

Warnings

Warnings

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
Active Ingredient

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

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

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

Uses

Aids in the prevention of dental cavities

Section 51945-4 (51945-4)

Purpose

Anticavity

Warnings

Warnings

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
Active Ingredient (Active ingredient)

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

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

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: 2026-02-15T12:08:17.576029 · Updated: 2026-03-14T23:12:30.242816