Your browser does not support JavaScript! DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE BERRY (SODIUM FLUORIDE) LIQUID [AR MEDICOM INC]
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DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE BERRY (sodium fluoride) liquid
[AR Medicom Inc]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

Medicom

Denti-Care

Denti-Rinse

2% Neutral Sodium Fluoride Oral Rinse

Berry

1.9 L / 64 fl oz

NDC 64778-0448-1

NPN 80008542

Rx Only

10044Berry




For topical application to aid in the prevention of dental caries. Neutral pH is especially safe for crowns and restorations.

Directions:

1. Dispense 10mL of Denti-Rinse 2% Neutral Sodium Fluoride solution into a measuring cup.

2. Instruct patient to rinse vigorously for 1 minute with 10mL of the solution around and between teeth, and then expectorate.

3. For maximum benefit, repeat the rinse procedure with an additional 10mL.

4. Instruct patient not to eat, drink or rinse mouth for at least 30 minutes.

5. Denti-Rinse solution may also be applied full strength with a cotton tip applicator to teeth isolated with cotton rolls.


Medicinal ingredients: Sodium fluoride 2.0% w/w



Non-Medicinal ingredients: Citric acid (anhydrous), potassium sorbate, purified water, sorbitol, sucralose, red 33, red 40, fruit punch flavour

Warnings: KEEP OUT OF 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 40 degrees C or 104 degrees F.

Do not use if seal is broken.

Made in USA for: A.R. Medicom Inc. Montreal, Canada H8T 3J8

Questions: 1-800-361-2862 or www.medicom.com

Item Code 10044-B

UPC 686864000693

No. 112449

Rev.2

DENTI-CARE DENTI-RINSE  NEUTRAL SODIUM FLUORIDE ORAL RINSE BERRY
sodium fluoride liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64778-0448
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium fluoride (fluoride ion) fluoride ion.02 g  in 1 mL
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0448-11900 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2001
Labeler - AR Medicom Inc (247876295)

Revised: 2/2010
 
AR Medicom Inc

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