FDA.reportPublic FDA data

Neutrarinse 2% Neutral Sodium Floride Oral Rinse RefreshMint

Manufacturer
Germiphene Corporation
Effective date
2017-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:43

Label at a glance#

ProductNeutrarinse 2% Neutral Sodium Floride Oral Rinse White Grape
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

Dispense up to 10 mL of Neutrarinse 2% Neutral Sodium Fluoride Solution into a measuring cup. Instruct patient to rinse vigorously for one minute with up to 10 mL of the solution arond and between teeth, then expectorate. DO NOT SWALLOW. Instruct patient not to eat, drink, or rinse mouth for at least 30 minutes. Neutrarinse 2% Neutral Sodium Fluoride Solution may also be applied full strength with cotton pledgets,...

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Neutral pH makes Neutrarinse especially safe for crowns and restorations.

Medicinal ingredient:

OTC - ACTIVE INGREDIENT SECTION

2.0% Neutral sodium fluoride

Non-medicinal ingredients:

INACTIVE INGREDIENT SECTION

Water, sodium phosphate dibasic, parabens, sorbitol, xylitol, sodium saccharin, ethanol, povidone, and flavouring agents.

Directions:

DOSAGE & ADMINISTRATION SECTION

Dispense up to 10 mL of Neutrarinse 2% Neutral Sodium Fluoride Solution into a measuring cup. Instruct patient to rinse vigorously for one minute with up to 10 mL of the solution arond and between teeth, then expectorate. DO NOT SWALLOW. Instruct patient not to eat, drink, or rinse mouth for at least 30 minutes.

Neutrarinse 2% Neutral Sodium Fluoride Solution may also be applied full strength with cotton pledgets, to teeth isolated with cotton rolls.

Warning:

WARNINGS SECTION

The product is intended for topical use only, not for internal use. Not recommended for use by children under 6 years of age.

Instruct patient not to eat, drink, or rinse mouth for at least 30 minutes. Do not use if tamper-evident seal is broken. Do not store in direct sunlight.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

White GrapeWhite GrapeRefreshMintRefreshMintRaspberry SplashRaspberry Splash

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251960sodium fluoride 2 % Oral RinsePSN1
251960sodium fluoride 20 MG/ML MouthwashSCD1
251960sodium fluoride 2 % Oral RinseSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61508-0526-12020-01-31C16284748780-19d75b9d0-8ec6-f424-e053-dadaa90a57ceNeutrarinse
61508-0527-12020-01-31C16284748780-19d75b9d0-8ec6-f424-e053-dadaa90a57ceNeutrarinse
61508-0528-12020-01-31C16284748780-19d75b9d0-8ec6-f424-e053-dadaa90a57ceNeutrarinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61508-0526-1Neutrarinse 2% Neutral Sodium Floride Oral Rinse RefreshMint2000 g in 1 BOTTLE, PLASTICRINSE20001
61508-0527-1Neutrarinse 2% Neutral Sodium Floride Oral Rinse White Grape2000 g in 1 BOTTLE, PLASTICRINSE20001
61508-0528-1Neutrarinse 2% Neutral Sodium Floride Oral Rinse Raspberry Splash2000 g in 1 BOTTLE, PLASTICRINSE20001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61508-0526NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE WHITE GRAPE (SODIUM FLUORIDE) RINSE NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE RASPBERRY SPLASH (SODIUM FLUORIDE) RINSE NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE REFRESHMINT (SODIUM FLUORIDE) RINSE [GERMIPHENE CORPORATION]1Legacy NDC, 1 package rows20170206_47a16b3b-4a8b-6446-e054-00144ff8d46c.zip
61508-0527NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE WHITE GRAPE (SODIUM FLUORIDE) RINSE NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE RASPBERRY SPLASH (SODIUM FLUORIDE) RINSE NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE REFRESHMINT (SODIUM FLUORIDE) RINSE [GERMIPHENE CORPORATION]1Legacy NDC, 1 package rows20170206_47a16b3b-4a8b-6446-e054-00144ff8d46c.zip
61508-0528NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE WHITE GRAPE (SODIUM FLUORIDE) RINSE NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE RASPBERRY SPLASH (SODIUM FLUORIDE) RINSE NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE REFRESHMINT (SODIUM FLUORIDE) RINSE [GERMIPHENE CORPORATION]1Legacy NDC, 1 package rows20170206_47a16b3b-4a8b-6446-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61508-052661508-0526-1
61508-052761508-0527-1
61508-052861508-0528-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
POVIDONEFZ989GH94EIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
POVIDONEFZ989GH94EIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
POVIDONEFZ989GH94EIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
47a16b3b-4a8c-6446-e054-00144ff8d46c47a16b3b-4a8b-6446-e054-00144ff8d46c2017-02-03WarningsExact identifier
spl id: 47a16b3b-4a8c-6446-e054-00144ff8d46c
spl set id: 47a16b3b-4a8b-6446-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.