DENTAKOTES- dentakotes gel 
Rapha Pharmaceuticals, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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ACTIVE INGREDIENTS

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

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™

PRINCIPAL DISPLAY PANEL

DentakoteS

DENTAKOTES 
dentakotes gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69953-553
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE6 [hp_X]  in 6 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]  in 6 [hp_X]
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE6 [hp_X]  in 6 [hp_X]
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS6 [hp_X]  in 6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69953-553-016 [hp_X] in 1 VIAL; Type 0: Not a Combination Product01/18/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/18/2023
Labeler - Rapha Pharmaceuticals, Inc. (079804155)

Revised: 1/2023
Document Id: f2a6518b-83a0-3cb5-e053-2995a90aadd4
Set id: f290512a-ffaf-ae5c-e053-2a95a90aa9e9
Version: 2
Effective Time: 20230119
 
Rapha Pharmaceuticals, Inc.