GELATO FLUORIDE - sodium fluoride aerosol, foam 
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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This is a prescription fluoride treatment foam used to help prevent dental decay.

Do not swallow. Keep out of reach of children. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture on incinerate container. Do not spray toward open flame. For professional use only.

Distilled water, Polaxamer, Triethanolamine, Phosphoric Acid, Sodium Saccharine, Sodium Laureth Sulfate, Hydrofluoric Acid, Xylitol, Potassium Hydroxide, Propellant A31.

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


Entire Label
GELATO FLUORIDE 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68400-117
Route of AdministrationDENTAL, TOPICAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE1.5375 g  in 125 g
Inactive Ingredients
Ingredient NameStrength
WATER 
POLOXAMER 407 
TROLAMINE 
PHOSPHORIC ACID 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SODIUM LAURETH SULFATE 
HYDROFLUORIC ACID 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68400-117-12125 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/02/2012
Labeler - Deepak Products, inc. (124886743)
Establishment
NameAddressID/FEIBusiness Operations
Deepak Products, inc.124886743manufacture

Revised: 02/2012
Document Id: a3a81712-f0b7-4bcd-8fb9-a77dce626061
Set id: b86cd5f7-8467-4824-b726-1743004c0e6d
Version: 1
Effective Time: 20120202
 
Deepak Products, inc.