Sorbet Rinse

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

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 Item Code (Source) NHRIC: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 Multilevel Packaging 1 NHRIC:68400-328-40 113.5 mL in 1 BOTTLE, PLASTIC None

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 (014769301)

Establishment
Name	Address	ID/FEI	Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc		014769301	manufacture (68400-328), label (68400-328)

Revised: 01/2022 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc