Gelato Perio Maintenance Rinse

Generic Name: stannous fluoride
Dosage Form: oral concentrate

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.

Active Ingredient:

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

Purpose:

Anticavitiy, antigingivitis, antihypersensitivity mouthrinse

Slideshow: Worried About Ebola? You’re More Likely to Get These 10 Serious Infections

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 is 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. 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.
  • Remove cap and replace with pump.
  • Roate spout counter clockwise to extend.
  • 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.

Gelato Perio Maintenance Rinse 
stannous fluoride concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68400-206
Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Stannous Fluoride (Fluoride Ion) Fluoride Ion 1.786 g  in 283.5 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
METHYLPARABEN  
PROPYLPARABEN  
SACCHARIN SODIUM  
Product Characteristics
Color      Score     
Shape Size
Flavor RASPBERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68400-206-10 283.5 g in 1 BOTTLE, PLASTIC
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. (078654194)
Registrant - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)
Establishment
Name Address ID/FEI Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 078654194 manufacture(68400-206), label(68400-206)
Revised: 05/2013
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.



Hide
(web3)