NEUTRAGEL- sodium fluoride gel, dentifrice

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Tillgänglig från:

Germiphene Corporation

Administreringssätt:

DENTAL

Receptbelagda typ:

OTC DRUG

Terapeutiska indikationer:

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.

Bemyndigande status:

unapproved drug other

Produktens egenskaper

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.
NEUTRAGEL
sodium fluoride gel, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 150 8 -0 370
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40
8 O)
FLUORIDE ION
1.1 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)
2.6 g in 10 0 g
Germiphene Corporation
WATER (UNII: 0 59 QF0 KO0 R)
8 6 .1 g in 10 0 g
GLYCERIN (UNII: PDC6 A3C0 OX)
10 g in 10 0 g
SO DIUM BENZO ATE (UNII: OJ245FE5EU)
0 .12 g in 10 0 g
ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)
0 .0 0 7 g in 10 0 g
SO DIUM CITRATE (UNII: 1Q73Q2JULR)
0 .0 9 3 g in 10 0 g
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING STA