Active Ingredients Section
MEDICINAL INGREDIENT: SODIUM FLUORIDE 2.0%
Neutral Rinse
FDA Label NDC 62007-210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ross Healthcare, Inc. for the product Neutral Rinse (NDC 62007-210). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients section, purpose section, children section, indications and use section, warnings section, dosage and administration section, inactive ingredient section, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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