DentiCare Pro-Gel: Package Insert and Label Information

DENTICARE PRO-GEL- sodium fluoride gel
AR 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.

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

10023-MM
(click image for full-size original)

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.

DENTICARE PRO-GEL
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-1233
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.02 g in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor MINT, WATERMELON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64778-1233-1 480 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/03/1999
Labeler — AR Medicom Inc (247876295)
Registrant — AR Medicom Inc (247876295)

Revised: 05/2014 AR Medicom Inc

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