GELATO NEUTRAL PH- sodium fluoride gel

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

INN（国际名称）:

SODIUM FLUORIDE

组成:

FLUORIDE ION 4.086 g in 454 g

给药途径:

DENTAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Fluoride Treatment Gel - A stable thixotropic fluoride treatment gel used to help prevent dental decay. - For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.

授权状态:

unapproved drug other

产品特点

GELATO NEUTRAL PH- SODIUM FLUORIDE GEL
MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK
PRODUCTS INC.
_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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ACTIVE INGREDIENT:
Sodium Fluoride 2%
PURPOSE:
Fluoride Treatment Gel
INDICATIONS AND USAGE:
A stable thixotropic fluoride treatment gel used to help prevent
dental decay.
For Professional Office Use Only. This product is not intended for
home or
unsupervised consumer use.
WARNINGS:
Keep out of reach of children.
Do not swallow. If product is accidentally swallowed in quantities
greater than would
normally occur with a treatment gel, seek medical help or contact a
Poison Conrol
Center right away.
Read directions carefully before using.
DOSAGE AND ADMINISTRATION:
Shake well before use. This is a four minute fluoride gel for
in-office patient use. It is
normally used as a preventative caries treatment twice a year.
1. After thorough prophylaxis, fill two single or one dual tray, one
third full with gel. Air
dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for four minutes.
3. Remove trays. Instruct patient to expectorate any excess gel and
not to eat or drink
for at least 30 minutes.
OTHER INFORMATION:
• Do not store above 25°C/77°F. Do not freeze.
INACTIVE INGREDIENTS:
Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid,
Polysorbate 20,
Potassium Hydroxide, Sodium Benzoate, Sodium Saccharin, Titanium
Dioxide, Water,
Xanthan Gum, Xylitol. May contain blue #1, green#3, red #3, red #40,
yellow #5
(tartrazine), yellow #6 as a color additive.
GELATO NEUTRAL PH
sodium fluoride gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:68400-114
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION -
UNII:Q80VPU408O)
FLUORI