GELATO NEUTRAL PH- sodium fluoride aerosol, foam

Gelato Neutral PH by

Drug Labeling and Warnings

Gelato Neutral PH by is a Prescription medication manufactured, distributed, or labeled by Deepak Products, inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

This is a prescription fluoride treatment foam used to help prevent dental decay.

WARNINGS

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.

INACTIVE INGREDIENT

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

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GELATO NEUTRAL PH 
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 68400-138
Route of Administration	DENTAL, TOPICAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.5 g  in 125 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
TROLAMINE (UNII: 9O3K93S3TK)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XYLITOL (UNII: VCQ006KQ1E)
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68400-138-04	125 g in 1 BOTTLE, SPRAY

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	Business Operations
Deepak Products, inc.		124886743	manufacture