Gelato APF Gel Pina Colada 16oz

GELATO APF GEL PINA COLADA 16OZ- 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.

  • 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 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 do not eat or drink for at least 30 minutes.

Citric Acid, FD&C Blue #1, FD&C Red #40, FD&C Yellow #5 (tartazine) as a color additive, FD&C Yellow #6, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xyltiol

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

GelatoPinaColada16oz
(click image for full-size original)

GELATO APF GEL PINA COLADA 16OZ
apf gel gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-107
Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 9.5 g in 454 g
Inactive Ingredients
Ingredient Name Strength
Hydrofluoric Acid
CITRIC ACID MONOHYDRATE
Magnesium Aluminum Silicate
Phosphoric Acid
Polysorbate 20
Sodium Benzoate
SACCHARIN SODIUM
Water
Xanthan Gum
Xylitol
Product Characteristics
Color Score
Shape Size
Flavor PINEAPPLE (Pina Colada) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68400-107-15 454 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/18/2012
Labeler — Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (078654194)
Registrant — Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)
Establishment
Name Address ID/FEI Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. 078654194 manufacture (68400-107), label (68400-107)

Revised: 12/2012 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

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