SORBET RINSE- sodium fluoride concentrate 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc

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Active Ingredient (before dilution):

Fluoride Ion 1.5%

Available from 3.3% Sodium fluoride.

Purpose:

Anticaries Treatment

Indications and Usage:

Warnings:

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.

LB.Sorbet Sodium Fluoride_4_OUT.jpg

SORBET RINSE 
sodium fluoride concentrate
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68400-328
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1702.5 mg  in 113.5 mL
Inactive Ingredients
Ingredient NameStrength
DMDM HYDANTOIN (UNII: BYR0546TOW)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-328-40113.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only05/10/2013
Labeler - 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(68400-328) , label(68400-328)

Revised: 4/2024
Document Id: 16dce3ea-b96a-24fe-e063-6394a90a1c18
Set id: 297143e7-c61b-4fe7-af44-80e0bca43161
Version: 7
Effective Time: 20240424
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc