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

Gelato 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.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert



FULL PRESCRIBING INFORMATION

Uses

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.   

  • 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.

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.

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 one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol

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

Gelato APF

Sodium Fluoride GEL

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:68400-121
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
titanium dioxide

Product Characteristics

Color
pink

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68400-121-15 454 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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