GELATO PERIO MAINTENANCE RINSE- stannous fluoride concentrate 
Mycone Dental Supply Co., Inc DBA Keystone Industries and 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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Active Ingredient:

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

Purpose:

Anticavity, 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 mist be used under the supervision of a dentist.

Warnings:

Directions:

Adults and children 6 years of age and older:

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.

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GELATO PERIO MAINTENANCE RINSE 
stannous fluoride concentrate
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68400-202
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.34 g  in 283.5 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Colorwhite (heavy liquid) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-202-10283.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2013
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
NameAddressID/FEIBusiness Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc014769301manufacture(68400-202) , label(68400-202)

Revised: 4/2024
Document Id: 16b27374-8a2b-4ee9-e063-6394a90ac92a
Set id: d2f0df92-d52f-4c9c-99d0-3cd2a025e5e9
Version: 6
Effective Time: 20240422
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.