Sheerfluorx FluorideTreatment

Generic Name: sodium fluoride
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

Sheer FluorX™ PEDO fluoride treatment is the ideal way to make in-office fluoride treatments easy, safer, faster, more comfortable, and more practical. Kids will love Sheer FluorX – no more trays, foams or gels that cause gagging and mess. The sheer film molds to teeth delivering fluoride exactly where you want it, eliminating gel running down the throat and being swallowed. The 5% sodium fluoride acidulated formula provides an effective and rapid uptake of fluoride to the teeth. Each film contains 0.4 grams (400 mg) of total composition including 20mg sodium fluoride, active ingredient.



  • Avoid eating or drinking while wearing the film.
  • Flush with copious amounts of water if accidentally
    placed in eye.
  • Keep out of reach of young children.
  • Not for use by children under the age of 12 without adult supervision.
  • Avoid contact with clothing.
  • Do not use if you have a known allergy to fluoride.
  • Do not wear for more than 60 minutes in a 24 hour period.
  • Avoid swallowing.
  • Attention - Refer to the instructions for use and complete information.
  • Use only as directed. Keep out of reach of small children and animals.
  • Storage Temperature - Store product at the indicated temperature (32°F/0°C to 100°F/38°C).
  • Do not store above 100°F (38°C). Do not freeze. Do not use beyond indicated shelf life.
  • Do not use if the packaging has been damaged, or if the seals are found to be broken or open.
Shelf Life: 2 years
  1. Use enclosed EZ opener to cut wrapper open.
  2. Remove shrink wrap from tray. Carefully remove film from tray. The sticky gel side faces up. You may use scissors to trim film to desired size.
  3. You may use scissors to trim film to desired size.
  4. 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.
  5. Starting at the front teeth, wrap the film onto the back side of the teeth. Use your fingers to firmly mold the film to your teeth. Repeat process for other arch.
  6. Leave the film in place for 15-60 minutes. DO NOT wear for more than 60 minutes in a 24 hour period.
  7. To remove, grasp corner of film and begin to loosen away from teeth. Rinsing with water may help.
  8. Continue removing film from all surfaces. The film may come away in pieces; this is normal. Avoid swallowing gel, rinse to sink.
  9. Brush teeth and gums to remove any remaining gel. Rinse to sink, avoid swallowing excess gel.

COMPLETE INSTRUCTIONS - Back Page

Patent Pending

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

SAL-CAI200C.1/28MAR2011

FRONT PANEL

Sheer FluorX PEDO

Fluoride Treatment

Chairside Strength - Home Applied.

Patent Pending

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.

Shelf Life: 2 years

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

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

SAL-PTI200A.1/15MAR2011

Back panel of Patient Guide

IMMEDIATE PACKAGE DISPLAY PANEL

Sheer FluorX PEDO

Fluoride Treatment

Chairside Strength - Home Applied.

Wear Time 15-60m

LOT: [lot number]

EXP: [expiration date]

Sodium fluoride, 20mg per film

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

Easier. Faster. Better.

TO REORDER:
Henry Schein
1.800.372.4346

Adult supervision of children is required.

Storage

[32°F/0°C to 100°F/38°C]

Patent Pending

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

For one-time use only.

Introductory Kit  Part #006-00133

Refill Kit  Part #006-00134

PAK-LA0200B.1/23MAR2011

OUTER PACKAGE - Back panel

TO REORDER: Henry Schein 1.800.372.4346

PACKAGE CONTENTS: 6) PEDO Patient Treatment Kits (Ieach containing 4 treatment trays), each contains 2 PEDO treatment films, 1 EZ opening tool.

See package insert for dosage information. Product expiration shown on Date/Lot label (24 months from date of manufacture). 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 broken.

REORDER # 006-00133

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

Patent Pending

STORAGE: [32°F/0°C to 100°F/38°C]

Expiration Date: [lot and expiration label]

[Barcode: 872320001322]

MADE IN CHINA

Adult supervision of children is required.

OUTER PACKAGE - Side panel

Sheer FluorX PEDO

Ingredients: Water/eau, xylitol, glycerin, sodium fluoride, peppermint oil, sucralose, proprietary polymer.

NDC# 1406000503

Fluoride Treatment

Sheer FluorX PEDO

Fluoride Treatment

Patient Treatment Kit PEDO

Chairside Strength - Home Applied.

Net Qty: 8 - 0.4 grams per film

Active ingredient: Sodium fluoride, 20mg/film

SHEER FLUORX PEDO  FLUORIDE TREATMENT
sodium fluoride film
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:14060-006
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium fluoride (fluoride ion) sodium fluoride 20 mg
Inactive Ingredients
Ingredient Name Strength
Water  
Glycerin  
Xylitol  
Sucralose  
Product Characteristics
Color      Score     
Shape Size
Flavor PEPPERMINT (Peppermint Oil) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:14060-006-03 4 TRAY (TRAY) in 1 PACKAGE
1 2 FILM (FILM) in 1 TRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/15/2011
Labeler - CAO Group, Inc. (102422578)
Revised: 06/2011
 
CAO Group, Inc.



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