Active Ingredients
Methyl Salicylate 6x, Ferrum Phosphoricum 6x, Bellis Perennis 6x, Aconitum Napellus 6x
Dentakotes
FDA Label NDC 69953-553
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rapha Pharmaceuticals, Inc. for the product Dentakotes (NDC 69953-553). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, use, keep out of reach of children, directions, warnings, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Plaque, Anti-Gingivitis
Use
Helps to decrease the adhesion of bacterial deposits, bio-toxins, and the consequences of gingivitis.
Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Apply to natural teeth and dental prosthetics, bonds immediately.
Warnings
In case of overdose, seek medical attention or contact a Poison Control Center (1-800-222-1222) right away.
Inactive Ingredients
Silicone Oil
Other Information
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
Dentakotes (Dentakote S)
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