DentiCare Pro-Foam: Package Insert and Label Information

DENTICARE PRO-FOAM- sodium fluoride aerosol, foam
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.

Keept out of reach of children. Avoid spraying towards open flame. Store at room temperature. Do not expose to excessive hat over 40C or 104F. Contents under pressure. Do not pucture or incinerate. Do not use if seal is broken.

10037-CM
(click image for full-size original)

Medicom

DentiCare Pro-Foam

2.72% Topical Sodium Fluoride Foam

CitrusMint

NDC 64778-1371-1

10037-CM

Purified water, sucralose, sodium phosphate monobasic, xylitol, cocamidopropyl betaine, poloxamer 407, orange flavor, peppermint oil

Following prophylaxis treatment, fill 1/4 of tray with foam. To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray. Insert tray, have patient bite down of lightly for a minimun of 60 seconds, up to 4 minutes, remove tray and have patient not eat, drink or rinse for 30 minutes after the treatment.

DENTICARE PRO-FOAM
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-1371
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g in 1 g
Product Characteristics
Color Score
Shape Size
Flavor CITRUS, MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64778-1371-1 125 g in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2003
Labeler — AR Medicom Inc (247876295)
Registrant — AR Medicom Inc (247876295)

Revised: 05/2014 AR Medicom Inc

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