Your browser does not support JavaScript! GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.]
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GELATO NEUTRAL PH (sodium fluoride) aerosol, foam
[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

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 NEUTRAL PH 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68400-138
Route of AdministrationDENTAL, TOPICAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.5 g  in 125 g
Inactive Ingredients
Ingredient NameStrength
WATER 
POLOXAMER 407 
DECYL GLUCOSIDE 
SODIUM LAURETH SULFATE 
TROLAMINE 
PHOSPHORIC ACID 
SACCHARIN SODIUM 
SODIUM BENZOATE 
XYLITOL 
HYDROFLUORIC ACID 
POTASSIUM HYDROXIDE 
DMDM HYDANTOIN 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68400-138-04125 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/11/2011
Labeler - Deepak Products, inc. (124886743)
Establishment
NameAddressID/FEIBusiness Operations
Deepak Products, inc.124886743manufacture

Revised: 08/2011
Document Id: 202c46b4-9136-4bce-8cee-82718ebb3818
Set id: ba5c415e-2a44-4b49-b85a-55984e3131b8
Version: 3
Effective Time: 20110811
 
Deepak Products, inc.

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