GELATO PERIO MAINTENANCE RINSE- stannous fluoride concentrate

Gelato Perio Maintenance Rinse by

Drug Labeling and Warnings

Gelato Perio Maintenance Rinse by is a Prescription medication manufactured, distributed, or labeled by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc., Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Stannous Fluoride 0.63% Concentrate (0.12% w/v fluoride ion).

Purpose:

Anticavitiy, antigingivitis, antihypersensitivity mouthrinse

Indications and Usage:

Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product must be used under the supervision of a dentist.

Warnings:

• Keep out of reach of children.
• Do not swallow. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
• Do not use until diluted.
• This product may produce surface staining of the teeth.
• This product may produce surface staining of the teeth. Adequate tooth-brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Directions:

Adults and children 6 years of age and older:

• Do not use before mixing with water. Use immediately after preparing the rinse.
• Shake concentrate well before mixing with water.
• Remove cap and replace with pump.
• Rotate spout counter clockwise to extend.
• Depress pump until rinse comes to the tip of the pump.
• Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.
• Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
• Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 6 years of age: Consult a dentist or doctor.

Inactive Ingredients:

Flavor, Glycerin, Methyl paraben, Propyl paraben and Sodium Saccharin.

Other Information:

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GELATO PERIO MAINTENANCE RINSE 
stannous fluoride concentrate

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 68400-206
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.340 g  in 283.5 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	white (heavy liquid)	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68400-206-10	283.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2013

Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)

Registrant - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)

Establishment
Name	Address	ID/FEI	Business Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc		014769301	manufacture(68400-206) , label(68400-206)