DENTICARE PRO-RINSE- sodium fluoride rinse 
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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10044-MM (NDC 1443) MelonMint Oral Rinse
DentiCare Pro-Rinse 2% Neutral Sodium Fluoride

Keep out reach of children. For professional use only. Not recommended for use by children under 6 years of age. Do not swallow. Store at room temperature. Do not expose to excessive heat over 40C or 104F. Do not use if seal is broken.

Medicom

DentiCare Pro-Rinse

2% Neutral Sodium Fluoride Oral Rinse

NDC 64778-1443-1

10044-MM

Citric Acid, potassium sorbate, purified water, sorbitol, sucralose, peppermint oil, melon flavor, sodium hydroxide.

Topical anti-caries solution. Neutral pH is safe for patients with crowns and restorations. Dispense 10 mL of slution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximun benefit, repeat the rinse procedure with additional 10 mL. Advise patient not to eat, drink or rinse for 30 minutes after application. Pro-Rinse solution may also be applied with a cotton tip applicator to teeth isolated with cotton rolls.

10044-MM

DENTICARE PRO-RINSE 
sodium fluoride rinse
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-1443
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:64778-1443-11900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/200108/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/200108/28/2017
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)

Revised: 4/2019
 
AMD Medicom Inc.