Label: NEUTRAL RINSE - sodium fluoride liquid

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

Drug Label Information

Updated 10/11

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS SECTION

    MEDICINAL INGREDIENT: SODIUM FLUORIDE 2.0%

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  • PURPOSE SECTION

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

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  • CHILDREN SECTION

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

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  • INDICATIONS AND USE SECTION

    AID IN THE PREVENTION OF DENTAL CARIES

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  • WARNINGS SECTION

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

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  • 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.

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  • INACTIVE INGREDIENT SECTION

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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    NEUTRAL RINSE 
    sodium fluoride liquid
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-210
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color blue (BLUE 1) Score     
    Shape Size
    Flavor MINT (COOL PEPERMINT) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62007-210-64 1893 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 09/01/2011
    Labeler - Ross Healthcare, Inc. (244249012)
    Registrant - Ross Healthcare, Inc. (244249012)
    Establishment
    Name Address ID/FEI Business Operations
    Ross Healthcare, Inc. 244249012 manufacture
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