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-CM (NDC 1231) CitrusMint Gel
DentiCare Pro-Gel 2% Neutral Sodium Fluoride

Keep out of reach of children. Store at room temperature. 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 Application

CitrusMint

10023-CM

NDC 64778-1231-1

Purified water, saccharin sodium, hydroxyethyl cellulose, phosphoric acid, orange flavor, peppermint oil, sodium hydroxide

Following prophylaxis treatment, fill 1/3 of tray with ge. Insert tray in the 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-CM

DENTICARE PRO-GEL 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-1231
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
FlavorCITRUS, MINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-1231-1480 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: 860f92d6-2b0d-4c8b-e053-2a91aa0a7aa6
Set id: e4f4f2f1-628f-46ba-ad27-dadbc10b71e1
Version: 2
Effective Time: 20190408
 
AMD Medicom Inc