DentaKoteS

Manufacturer
Rapha Pharmaceuticals, Inc.
Effective date
2023-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:47

Label at a glance#

ProductDentaKoteS
Active ingredientMETHYL SALICYLATE, ACONITUM NAPELLUS, FERROSOFERRIC PHOSPHATE, BELLIS PERENNIS
Label structure9 sections

Dosage and administration

Apply to natural teeth and dental prosthetics, bonds immediately.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 6x, Ferrum Phosphoricum 6x, Bellis Perennis 6x, Aconitum Napellus 6x

PURPOSE

OTC - PURPOSE SECTION

Anti-Plaque, Anti-Gingivitis

USE

INDICATIONS & USAGE SECTION

Helps to decrease the adhesion of bacterial deposits, bio-toxins, and the consequences of gingivitis.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply to natural teeth and dental prosthetics, bonds immediately.

WARNINGS

WARNINGS SECTION

In case of overdose, seek medical attention or contact a Poison Control Center (1-800-222-1222) right away.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Silicone Oil

OTHER INFORMATION

DESCRIPTION SECTION

DentaKoteS™

DentaKote-S™ is a super hydrophobic prophylactic proprietary gel coating formulation. Used to help eliminate root sensitivity on natural teeth. It is a safe and effective homeopathic treatment. It provides immediate relief of cold-related sensitivity to the root surfaces in vital, non-diseased teeth (no underlying pathology). Supplied in a single disposable patient applicator for use on the exposed root surfaces of natural teeth due to gum recession.

DentaKote-S™ is a self-bonding silicone formulation developed by a dentist to be bio-compatible, safe, and pH stable. It is proven effective with proper use, and the clinical guidelines are followed.

Benefits of DentaKoteS™

  • Odorless & tasteless
  • Improve & simplify oral hygiene habits
  • Simple to apply by staff
  • Eliminate root sensitivity instantly
  • Some insurance coverage under “desensitizing agents”
  • Passive revenue generator for the practice

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DentakoteSDentakoteS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69953-553-012025-01-30C16284748780-12cef2736-933e-d83d-e063-dadaa90ab31ff290512a-ffaf-ae5c-e053-2a95a90aa9e9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69953-553-01DentaKoteS6 [hp_X] in 1 VIALGEL62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69953-553DENTAKOTES GEL [RAPHA PHARMACEUTICALS, INC.]21 package rows20230121_f290512a-ffaf-ae5c-e053-2a95a90aa9e9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69953-55369953-553-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f2a6518b-83a0-3cb5-e053-2995a90aadd4f290512a-ffaf-ae5c-e053-2a95a90aa9e92023-01-19WarningsExact identifier
spl id: f2a6518b-83a0-3cb5-e053-2995a90aadd4
spl set id: f290512a-ffaf-ae5c-e053-2a95a90aa9e9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.