MedPath

GuruNanda Anti-Cavity

GuruNanda Anti-Cavity Oral Rinse

Approved
Approval ID

3b07b72f-4efc-eb0f-e063-6294a90a70a8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

GURUNANDA, LLC

DUNS: 079671169

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70708-890
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (13)

SODIUM FLUORIDEActive
Quantity: 0.2 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
DISODIUM PHOSPHATEInactive
Code: 22ADO53M6F
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SODIUM CHLORITEInactive
Code: G538EBV4VF
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PEG-40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
STEVIA LEAFInactive
Code: 6TC6NN0876
Classification: IACT
LEVOMENTHOLInactive
Code: BZ1R15MTK7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

0877

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

Uses

Aids in the prevention of dental cavities

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

Warnings

Warnings

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).

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active ingredient

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Purpose

Anticavity

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

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 SAFETY INFORMATION

LOINC: 60561-8Updated: 8/1/2025

Other information

  • Do not use if printed seal is broken or missing
  • Recommended storage temperature 59°F-77°F (15°C-25°C)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

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

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