DENTICARE PRO-GEL- sodium fluoride gel 
AMD Medicom Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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10023-MM (NDC 1233) MelonMint Gel
DentiCare Pro-Gel 2% Neutral Sodium Fluoride

Keep out of reach of children. Store at room temperatue. Do not expose to excessive heat over 40C or 104F. Do not use if seal is broken

Medicom

DentiCare Pro-Gel

2% Neutral Sodium Fluoride Gel for Topical Fluoride Application 

MelonMint

NDC 64778-1233-1

10023-MM

Purified water, saccharin sodium, hydroxyethyl cellulose, phosphoric acid, melon flavour, peppermint oil, sodium hydroxide.

Following prophylaxis treatment, fill 1/3 of tray with gel, insert tray in patient's mouth, have patient bite down lightly for 4 minutes, remove tray and have patient expectorate excess. Advise patient not to eat, drink or rinse for 30 minutes after application.

10023-MM

DENTICARE PRO-GEL 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-1233
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 1 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT, WATERMELONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-1233-1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/03/199908/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/03/199908/28/2017
Labeler - AMD Medicom Inc (256880576)
Registrant - AMD Medicom Inc (256880576)

Revised: 4/2019
Document Id: 860f9a5f-71d8-4be4-e053-2991aa0ae617
Set id: e7f84ec5-e6c7-4fb3-b44e-a7f9a2edca74
Version: 2
Effective Time: 20190408
 
AMD Medicom Inc