NEUTRAGEL- sodium fluoride gel, dentifrice

Neutragel by

Drug Labeling and Warnings

Neutragel by is a Otc medication manufactured, distributed, or labeled by Germiphene Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Recommended use:

A topical anticaries preparation for dental use only.

PURPOSE

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:

0.5% fluoride ion (from 1.1% sodium fluoride)

Non-medicinal ingredients:

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

Directions:

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:

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEUTRAGEL 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61508-0370
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)	2.6 g  in 100 g
WATER (UNII: 059QF0KO0R)	86.1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	10 g  in 100 g
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.12 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.007 g  in 100 g
SODIUM CITRATE (UNII: 1Q73Q2JULR)	0.093 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61508-0370-1	120 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/06/2017
2	NDC: 61508-0370-2	450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/06/2017

Labeler - Germiphene Corporation (206412512)

Establishment
Name	Address	ID/FEI	Business Operations
Germiphene Corporation		206412512	manufacture(61508-0370)