Your browser does not support JavaScript! NEUTRAL RINSE (SODIUM FLUORIDE) LIQUID [ROSS HEALTHCARE, INC.]
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NEUTRAL RINSE (sodium fluoride) liquid
[Ross Healthcare, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

ACTIVE INGREDIENTS SECTION

MEDICINAL INGREDIENT: SODIUM FLUORIDE 2.0%

PURPOSE SECTION

FOR TOPICAL USE TO AID IN THE PREVENTION OF DENTAL CARIES.

CHILDREN SECTION

NOT RECOMMENDED FOR USE BY CHILDREN UNDER 6 YEARS OF AGE.

INDICATIONS AND USE SECTION

AID IN THE PREVENTION OF DENTAL CARIES

WARNINGS SECTION

CAUTIONS AND WARNINGS: FOR PROFESSIONAL USE ONLY. DO NOT SWALLOW. US LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

DOSAGE AND ADMINISTRATION SECTION

DIRECTIONS FOR USE:

1. DISPENSE 10ML OF SOLUTION INTO A MEASURING CUP.

2. INSTRUCT PATIENT TO RINSE VIGOROUSLY FOR I MINUTE AND THEN EXPECTORATE.

3. FOR MAXIMUM BENEFIT, HAVE PATIENT REPEAT PROCEDURE WITH AN ADDITIONAL 10ML.

4. DO NOT EAT OR DRINK FOR 30 MINUTES AFTER USE.

INACTIVE INGREDIENT SECTION

NON MEDICINAL INGREDIENTS: POTASSIUM SORBATE, PURIFIED WATER, SODIUM SACCHARIN, XYLITOL, MINT FLAVOR, BLUE 1.

PACKAGE LABEL

PCxx  PROFESSIONAL CARE PRODUCTS NEUTRAL RINSE  2.0% SODIUM FLUORIDE  COOL PEPERMINT

NET CONTENTS: 64 FL. OZ

NDC # 62007-210-64

ROSS HEALTHCARE INC. TO FIND AN AUTHORIZED DEALER NEAR YOU VISIT OR CALL WWW.ROSSHEALTHCARE.ORG  1-800-663-8303 

DELTA,BC MADE IN CANADA V3M 6J8

NEUTRAL RINSE LABEL

NEUTRAL RINSE 
sodium fluoride liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:62007-210
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE 
WATER 
SACCHARIN SODIUM DIHYDRATE 
XYLITOL 
Product Characteristics
Colorblue (BLUE 1) Score    
ShapeSize
FlavorMINT (COOL PEPERMINT) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:62007-210-641893 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/2011
Labeler - Ross Healthcare, Inc. (244249012)
Registrant - Ross Healthcare, Inc. (244249012)
Establishment
NameAddressID/FEIBusiness Operations
Ross Healthcare, Inc.244249012manufacture

Revised: 10/2011
Document Id: 3e601d61-9ee7-41e9-be41-026389890ac9
Set id: 58363af8-fe2e-4f1f-80ce-e984c2696907
Version: 1
Effective Time: 20111018
 
Ross Healthcare, Inc.

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