Your browser does not support JavaScript! GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]
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GELATO APF (sodium fluoride) gel
[Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

  • 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% effectivess).

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

GelatoStrawberry16oz

GELATO APF 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68400-111
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 
XYLITOL 
FD&C RED NO. 40 
TITANIUM DIOXIDE 
Product Characteristics
ColorredScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-111-15454 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(68400-111), label(68400-111)

Revised: 11/2013
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

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