NEUTRAGEL- sodium fluoride gel, dentifrice 
Germiphene Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Neutragel

Recommended use:

A topical anticaries preparation for dental use only.

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.

227 g450 g

NEUTRAGEL 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0370
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0370-1120 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2017
2NDC:61508-0370-2450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/06/2017
Labeler - Germiphene Corporation (206412512)
Establishment
NameAddressID/FEIBusiness Operations
Germiphene Corporation206412512manufacture(61508-0370)

Revised: 2/2017
Document Id: 47a06f42-3145-354e-e054-00144ff8d46c
Set id: 47a06f42-3144-354e-e054-00144ff8d46c
Version: 1
Effective Time: 20170203
 
Germiphene Corporation