Gelato Neutral Sodium Fluoride Foam

Generic Name: sodium fluoride

Dosage Form: aerosol, foam
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
  

GELATO NEUTRAL PH  sodium fluoride  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68400-134 Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.5 g  in 125 g

Inactive Ingredients Ingredient Name Strength 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      Shape Size Flavor MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68400-134-12 125 g In 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/11/2011

Labeler - Deepak Products, inc. (124886743)

Establishment
Name	Address	ID/FEI	Operations
Deepak Products, inc.		124886743	manufacture

Revised: 08/2011Deepak Products, inc.