Neutragel

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#

ProductNeutragel

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Dosage and administration

1. Fill Germiphene brand disposable Gel Trays. After thorough prophylaxis, air dry teeth and insert trays for four minutes. 2. Remove trays and excess gel.

Label contents#

Full prescribing information#

Recommended use:

INDICATIONS & USAGE SECTION

A topical anticaries preparation for dental use only.

OTC - PURPOSE SECTION

1.1% Neutral sodium fluoride gel for topical fluoride gel treatments. Neutragel provides 0.5% fluoride ion from sodium fluoride in a neutral (pH7), unflavored, unsweetened, stabilized gel base. The special formulation is non-etching on porcelain or ceramic filled restorations. Ideal for chemotherapy and Zerostomia patients.

Medicinal ingredient:

OTC - ACTIVE INGREDIENT SECTION

0.5% fluoride ion (from 1.1% sodium fluoride)

Non-medicinal ingredients:

INACTIVE INGREDIENT SECTION

Purified water, glycerin carboxymethylcellulose sodium, sodium benzoate, sodium citrate, and citric acid anhydrous.

Directions:

DOSAGE & ADMINISTRATION SECTION

1. Fill Germiphene brand disposable Gel Trays. After thorough prophylaxis, air dry teeth and insert trays for four minutes. 2. Remove trays and excess gel.

Warning/Caution:

WARNINGS SECTION

Do not eat, drink, or rinse for 30 minutes after treatment. Do not use if tamper-evident foil 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

227 g450 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1486566	sodium fluoride 1.1 % Oral Gel	PSN	1
1486566	sodium fluoride 0.011 MG/MG Oral Gel	SCD	1
1486566	sodium fluoride 1.1 % Oral Gel	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61508-0370-1	2020-01-31	C162847	48780-1	9d75b9d0-623b-f424-e053-dadaa90a57ce	Neutragel
61508-0370-2	2020-01-31	C162847	48780-1	9d75b9d0-623b-f424-e053-dadaa90a57ce	Neutragel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61508-0370-1	Neutragel	120 g in 1 BOTTLE, PLASTIC	GEL, DENTIFRICE	120		1
61508-0370-2	Neutragel	450 g in 1 BOTTLE, PLASTIC	GEL, DENTIFRICE	450		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61508-0370	NEUTRAGEL (SODIUM FLUORIDE) GEL, DENTIFRICE [GERMIPHENE CORPORATION]	1	Legacy NDC, 2 package rows	20170206_47a06f42-3144-354e-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Neutragel
Sodium fluoride
CARBOXYMETHYLCELLULOSE SODIUM
WATER
GLYCERIN
SODIUM BENZOATE
ANHYDROUS CITRIC ACID
FLUORIDE ION
SODIUM CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61508-0370	61508-0370-1, 61508-0370-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
SODIUM CITRATE	1Q73Q2JULR	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
47a06f42-3145-354e-e054-00144ff8d46c			47a06f42-3144-354e-e054-00144ff8d46c	2017-02-03	Warnings	Exact identifier spl id: 47a06f42-3145-354e-e054-00144ff8d46c spl set id: 47a06f42-3144-354e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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