Gelato X APF description, usages, side effects, indications, overdosage, supplying and lots more!

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Gelato X APF

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


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient:

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Purpose:

Anticaries Treatment

Indications and Usage:

  • A stable thixotropic fluoride treatment gel used to help prevent dental decay.
  • For professional use only. This product is not intended for home or unsupervised 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 control center right away.
  • Read directions carefully before using.

Dosage and Administration:

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

  • After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
  • Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
  • Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other Information:

  • Store at a controlled room temperature 59°-86°F (15°-30°C).
  • Protect from freezing.

Inactive Ingredients:

Citric Acid, FD&C Red #40, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol

Gelato X APF

Gelato X APF

Sodium Fluoride GEL

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:68400-609
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 5.6 g

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
magnesium aluminum silicate
phosphoric acid
POLYSORBATE 20
SODIUM BENZOATE
saccharin sodium
water
XANTHAN GUM
Xylitol
FD&C RED NO. 40
FD&C YELLOW NO. 5
titanium dioxide

Product Characteristics

Color
orange

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68400-609-15 454 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-12-14


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