MedPath

GuruNanda Anti-Gingivitis

Approved
Approval ID

386f8d92-8186-eed7-e063-6394a90a87e1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 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.

Cetylpyridinium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70708-012
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Cetylpyridinium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (9)

CETYLPYRIDINIUM CHLORIDEActive
Quantity: 0.05 g in 1 mL
Code: D9OM4SK49P
Classification: ACTIB
DISODIUM PHOSPHATEInactive
Code: 22ADO53M6F
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
STEVIA LEAFInactive
Code: 6TC6NN0876
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SPEARMINT OILInactive
Code: C3M81465G5
Classification: IACT
LEMON OILInactive
Code: I9GRO824LL
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

08883

INDICATIONS & USAGE SECTION

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

Directions

**Adults and children 12 years of age and older:**Vigorously swish 20 mL (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.

**Children 6 years to under 12 years:**Supervise use.

**Children under 6 years of age:**Do not use.

OTC - ACTIVE INGREDIENT SECTION

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

Active Ingredient

Cetylpyridinium Chloride 0.05%

OTC - PURPOSE SECTION

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

Purpose

Antigingivitis/Antiplaque

WARNINGS SECTION

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

Warnings

Warnings

Stop use and ask a dentist if

  • Gingivitis, bleeding, or redness persists for more than 2 weeks
  • You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontits, a serious form of gum disease

Keep out of reach of children under 6 years of age.

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

DOSAGE & ADMINISTRATION SECTION

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

Other Information

  • Do not use if printed safety seal on the bottle's neck 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

Citric Acid, Disodium Phosphate, Glycerin, Lemon Oil, Poloxamer 407, Spearmint Oil, Stevia Leaf Extract, Water

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