GELATO APF GEL COTTON CANDY 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.

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  • 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.

Citric Acid, FD&C Blue #1, 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

GelatoCottonCandy16oz

GELATO APF GEL COTTON CANDY 16OZ 
apf gel gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68400-120
Route of AdministrationDENTAL, TOPICAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION9.5 g  in 454 g
Inactive Ingredients
Ingredient NameStrength
Hydrofluoric Acid 
CITRIC ACID MONOHYDRATE 
Magnesium Aluminum Silicate 
Phosphoric Acid 
Polysorbate 20 
Sodium Benzoate 
SACCHARIN SODIUM 
Water 
Xanthan Gum 
Xylitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-120-15454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/14/2012
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
NameAddressID/FEIBusiness Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.078654194manufacture(68400-120), label(68400-120)

Revised: 2/2013
Document Id: f2ddf8ef-9997-48eb-85d6-73f7e73c8b6e
Set id: 26f3c9a5-7181-4d82-8fa2-21cebd090620
Version: 1
Effective Time: 20130226
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.