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Neutral Rinse (Gelato sodium fluoride) Package Insert

Status:
Prescription (Rx) Facts
Strength:
2 mL/100 mL
Brand names:
Active ingredient:
Similar drugs:

Prescribing information (package insert) - Neutral Rinse

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. 1. DISPENSE 10ML OF SOLUTION INTO A MEASURING CUP.
  2. 2. INSTRUCT PATIENT TO RINSE VIGOROUSLY FOR I MINUTE AND THEN EXPECTORATE.
  3. 3. FOR MAXIMUM BENEFIT, HAVE PATIENT REPEAT PROCEDURE WITH AN ADDITIONAL 10ML.
  4. 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.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: OTC MONOGRAPH FINAL 355 · View the label on DailyMed

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Drug information for Neutral Rinse

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Sodium fluoride 2 mL/100 mL
Dosage form Liquid
Route Topical
Marketing status not in the current FDA NDC Directory
Company (applicant) Ross Healthcare, Inc.
FDA approval OTC MONOGRAPH FINAL 355OTC monograph
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
2 mL/100 mL – 1893 ml in 1 bottle NDC 62007-210-64

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.