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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10021-MM (NDC 1213) MelonMint Gel
DentiCare Pro-Gel 2.72% Topical Sodium Fluoride

Keep out of reach of children. For professional use only. Not recommended for children under 18 months of age. Stoe at room temprature. Do not expose to excessive heat over 40C or 104F. Do not use if seal is broken.

Medicom

DentiCare

Pro-Gel

2.72% Topical Sodium Fluoride Gel

MelonMint

10021-MM

NDC 64778-1213-1

Carboxymethylcellulose sodium, phosphoric acid, purified water, saccharin sodium, melon flavor, peppermint oil.

Following Prophylaxis treatment, fill 1/3 of tray with gel. Insert tray in the patient's mouth, have patent bite down lightly for 60 seconds, remove tray and have patient expectorate excess. Advise patient not to eat, drink or rinse for 30 minutes after application.

1021-mm

DENTICARE PRO-GEL 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-1213
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g  in 1 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorWATERMELON, MINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-1213-1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/200508/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/200508/28/2017
Labeler - AMD Medicom Inc (256880576)
Registrant - AMD Medicom Inc (256880576)

Revised: 4/2019
Document Id: 860f9a5f-71f6-4be4-e053-2991aa0ae617
Set id: 844f0488-f35d-449f-b47f-5b9ef961c39d
Version: 2
Effective Time: 20190408
 
AMD Medicom Inc