Sheerdesenz Desensitizing Treatment

Generic Name: potassium nitrate
Dosage Form: dental film

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.

Product Information

[Patient Kit Information Panel]

TO REORDER: 1.877.236.4408

www.caogroup.com

PACKAGE CONTENTS: 4) desensitizing treatments

See package insert for dosage information. Rx Only. Dispose of properly after use. For complete safety information see product MSDS. Do not use if the packaging has been damaged, or if the safety seals are found to be broken.

REORDER #: 006-00104

Manufactured by CAO (China) Medical Equipment Co., Ltd. for CAO Group, Inc.

4628 West Skyhawk Drive

West Jordan, UT 84084

U.S.A.

877-236-4408 (tel)

801-256-9287 (fax)


www.caogroup.com

Expiration date:

MADE IN CHINA

[Side panels for the Patient Pack]

SheerDesenZ

Active Ingredient: Potassium nitrate, 12mg/film

Other Ingredients: Proprietary polymer, water/eau, xylitol, glycerin, poly(acrylic acid), peppermint oil, sucralose, potassium hydroxide

NDC#: 1406000304


[Front side of patient instruction card]

SheerDesenZ

Desensitizing Treatment

Simple.Comfort.Now

Disclaimer: CAO Group believes this information to be accurate and is offered only for the benefit of its customers for use of the product under proscribed conditions. This document is not to eb considered a warranty or guarantee of product performance, and CAO Group is not legally bound to such claims based on this document.

Shelf Life: 2 years

Manufactured by CAO (China) Medical Equipment Co., Ltd. for CAO Group, Inc.

4628 West Skyhawk Drive

West Jordan, UT 84084 U.S.A.

www.caogroup.com

13 Sept 2010
SAL-CSG010B.1


[Back panel of patient guide]

Sheer DesenZ

Desensitizing Treatment

Wear 01:00:00

Description

Sheer DesenZ™ desensitizing treatment is an easy, fast way to relieve oral pain and discomfort associated with dental procedures or even the hot/cold thermal changes teeth may experience. The thin, flexible film stays where it is placed molding to the teeth and gums to deliver relief exactly where it is needed. Yet it is easily removed when comfort is achieved.


Counter Indications

• Do not smoke while wearing the film.
• Avoid eating while wearing the film.
• Flush with copious amounts of water if accidentally placed in eye.
• Keep out of reach of young children.
• Avoid contact with clothing.


Instructions

  1. Use enclosed tool to cut wrapper open.
  2. Remove shrink wrap from tray. Carefully remove film from tray. The sticky gel side faces up. Position the film so it is centered on the arch. Firmly apply the film to the teeth, with the edge of the film just extending onto the gums.
  3. Starting at the front teeth, wrap the film around the edge of the teeth and onto the back side of the teeth. Use your fingers to firmly mold the film to your teeth.
  4. Remove the smaller film and position it over the premolars and molars on one side of your mouth. Apply the smaller piece as described above.
  5. Wear for a maximum of one hour, or until sensitivity is gone. Repeat as directed by your dental professional.
  6. To remove, grasp corner of film and begin to loosen away from teeth.
  7. If film becomes difficult to remove, rinse with water.
  8. Continue removing film from all surfaces. The film may come away in pieces; this is normal.
  9. Brush teeth and gums to remove any remaining gel.

[Complete Instructions Back Page]

Caution: Federal law restricts this device to sale by or on the order of a licensed professional.

Disclaimer: CAO Group believes this information to be accurate and is offered only for the benefit of its customers for use of the product under proscribed conditions. This document is not to be considered a warranty or guarantee of product performance, and CAO Group is not legally bound to such claims based on this document.

Manufactured by CAO (China) Medical Equipment Co,. Ltd. for

CAO Group, Inc.

P 877.236.4408 F 801.256.9287
4628 West Skyhawk Drive, West Jordan, UT 84084-4501 U.S.A.
www.caogroup.com

13 Sept 2010
SAL-CAI010 B.1

[Immediate Package]

SheerDesenZ

Desensitizing Treatment

See carton for complete instructions and information. Keep out of reach of children.

For one-time use only.

CAO Group, Inc.

LOT#: [######]

EXP: [MMM YYYY]

[Patient Kit Principal Display Panel]

SheerDesenZ

Desensitizing Treatment

Patient Treatment Kit

Simple.Comfort.Now

Net Qty: 8) 0.4 gram films
Active Ingredient: Potassium nitrate, 12mg/film


SHEERDESENZ  DESENSITIZING TREATMENT
potassium nitrate film
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:14060-003
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
potassium nitrate (nitrate ion) potassium nitrate 12 mg
Inactive Ingredients
Ingredient Name Strength
Water 99 mg
Potassium hydroxide 0.4 mg
Glycerin 40 mg
Xylitol 86 mg
Product Characteristics
Color      Score     
Shape Size
Flavor PEPPERMINT (Peppermint Oil) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:14060-003-04 4 TRAY (TRAY) in 1 PACKAGE
1 3 FILM (FILM) in 1 TRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2010
Labeler - CAO Group, Inc. (102422578)
Revised: 10/2010
 
CAO Group, Inc.



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