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Sorbet Rinse

Generic Name: sodium fluoride
Dosage Form: oral concentrate

Active Ingredient (before dilution):

Fluoride Ion 1.5%

Available from 3.3% Sodium fluoride

Purpose:

Anticaries Treatment

Indications and Usage:

  • To be used under the direction of or as prescribed by a dental professional.
  • This is a prescription fluoride rinse used to help prevent dental decay.

Warnings:

  • Do not use before diluting with water.
  • Keep out of reach of children. Children under 6 years of age; consult a dentist or doctor prior to use.
  • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a rinse, seek medical help or contact a Poison Control Center right away.

Dilution Instructions:

Use only after properly diluting according to one of the following formulas. Mix with distilled water only.

A. For 0.2% fluoride ion, neutral pH mouth rinse (weekly treatment):

Pour entire contents of concentrate bottle (4oz or 113.5mL) into clean mixing quart bottle. Add 28oz (286mL) of distilled water and blend.

B. For 0.5% fluoride ion, neutral pH mouth rinse (for use as prescribed):

Pour entire contents of concentrate bottle (4oz or 113.5mL) into clean mixing bottle. Add 8oz (227mL) of distilled water and blend.  

Dosage and Administration:

1. At bedtime, brush and floss teeth thoroughly.

2. Pour out one tablespoon (1/3oz or 10mL) of the diluted solution.

3. Place in mouth and rinse for 60 seconds and expectorate (spit out).

4. Do not eat or drink for 30 minutes.

Other Information:

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

Inactive Ingredients:

DMDM Hydantoin, FD&C Blue #1, Flavoring, Polysorbate 20, Saccharin and Water.

Sorbet Rinse 
sodium fluoride concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68400-328
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1702.5 mg  in 113.5 mL
Inactive Ingredients
Ingredient Name Strength
DMDM HYDANTOIN  
POLYSORBATE 20  
SACCHARIN SODIUM  
WATER  
FD&C BLUE NO. 1  
Product Characteristics
Color blue Score     
Shape Size
Flavor PEPPERMINT Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68400-328-40 113.5 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
export only 05/10/2013
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (078654194)
Establishment
Name Address ID/FEI Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 078654194 manufacture(68400-328), label(68400-328)
Revised: 12/2013
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc



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