Label: NEUTRAL RINSE- sodium fluoride liquid

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: 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 Information

Updated October 18, 2011

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  • 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

  • INGREDIENTS AND APPEARANCE
    NEUTRAL RINSE 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorblue (BLUE 1) Score    
    ShapeSize
    FlavorMINT (COOL PEPERMINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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
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