SORBET RINSE- sodium fluoride concentrate

Sorbet Rinse by

Drug Labeling and Warnings

Sorbet Rinse by is a Prescription medication manufactured, distributed, or labeled by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SORBET RINSE 
sodium fluoride concentrate

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 68400-328
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1702.5 mg  in 113.5 mL

Inactive Ingredients
Ingredient Name	Strength
DMDM HYDANTOIN (UNII: BYR0546TOW)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68400-328-40	113.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2017

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	Business Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc		014769301	manufacture(68400-328) , label(68400-328)