GELATO APF- 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 
apf gel gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68400-120
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION5.6 g  in 454 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
Magnesium Aluminum Silicate 
Phosphoric Acid 
Polysorbate 20 
Sodium Benzoate 
SACCHARIN SODIUM 
Water 
Xanthan Gum 
FD&C BLUE NO. 1 
Xylitol 
TITANIUM DIOXIDE 
Product Characteristics
ColorblueScore    
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: 11/2013
Document Id: cadc3e5b-01bd-42b3-a416-3d39c3fd07af
Set id: 26f3c9a5-7181-4d82-8fa2-21cebd090620
Version: 2
Effective Time: 20131119
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.