Label: SHEERFLUORX FLUORIDE TREATMENT- sodium fluoride film

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 10/10

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Sheer FluorX™ fluoride treatment is the ideal way to make in-office fluoride treatments easy, 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 foam running down the throat and being swallowed. The 5% sodium fluoride acidulated formula provides an effective and long duration application of fluoride to the teeth.


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  • CONTRAINDICATIONS

    • Do not smoke during the fluoride treatment.
    • 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.
    • Avoid contact with clothing.
    • Do not use if you have a known allergy to fluoride.
    • Do not wear for more than 15 minutes in a 24 hour period.
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  • PRECAUTIONS

    • 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).
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  • STORAGE AND HANDLING

    • 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.
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  • DOSAGE & ADMINISTRATION

    1. Separate the paper layer from the plastic tray by pulling where indicated. The sticky gel side is against the plastic layer.
    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. Leave the film in place for 15 minutes. DO NOT wear for more than 15 minutes in a 24 hour period.
    5. Grasp corner of film and begin to loosen away from teeth.
    6. If film becomes difficult to remove, rinse with water.
    7. Continue removing film from all surfaces. The film may come away in pieces; this is normal.
    8. Brush teeth and gums to remove any remaining gel.
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  • WARNINGS AND PRECAUTIONS

    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

    SAL-CAI011B.1/28SEP2010

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  • PATIENT PACKAGE INSERT

    FRONT PANEL

    SheerFluorx

    Fluoride Treatment

    Chairside Strength - Home Applied.

    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-PTK002A.1/28SEP2010

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  • PATIENT PACKAGE INSERT

    Back panel of Patient Guide

    Patient Guide back panel

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  • INFORMATION FOR PATIENTS

    IMMEDIATE PACKAGE DISPLAY PANEL

    SheerFluorX

    Fluoride Treatment

    Chairside Strength - Home Applied.

    LOT: [lot number]

    EXP: [expiration date]

    CAO Group, Inc.

    Easier. Faster. Better.

    TO REORDER:
    Henry Schein
    1.800.372.4346

    Storage

    [32°F/0°C to 100°F/38°C]

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

    For one-time use only.

    PAK-LA0016C.1/28SEP2010

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  • DESCRIPTION

    OUTER PACKAGE - Back panel

    TO REORDER: Henry Schein 1.800.372.4346

    PACKAGE CONTENTS: 4) fluoride treatment packs, each containing 2 applicator films

    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 # 006-00103

    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

    STORAGE: [32°F/0°C to 100°F/38°C]

    Expiration Date: [lot and expiration label]

    [Barcode: 872320000820]

    MADE IN CHINA

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  • DESCRIPTION

    OUTER PACKAGE - Side panel

    Sheer FluorX

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

    NDC# 1406000504

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  • PRINCIPAL DISPLAY PANEL

    SheerFluorX

    Fluoride Treatment

    Patient Treatment Kit

    Chairside Strength - Home Applied.

    Net Qty: 8) 0.4 gram films

    Active ingredient: Sodium fluoride, 20mg/film

    Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    SHEERFLUORX  FLUORIDE TREATMENT
    sodium fluoride film
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:14060-005
    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 Marketing Start Date Marketing End Date
    1 NDC:14060-005-04 4 in 1 PACKAGE
    1 2 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)
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