Sheer Fluorx Pedo Fluoride Treatment label

Sheer Fluorx Pedo Fluoride Treatment

Sheer Fluorx Pedo Fluoride Treatment Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

There is currently no usage information available for this product. We apologize for any inconvenience.

History

There is currently no drug history available for this drug.

Other 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.

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 Manufacturers

  • Sheer Fluorx Pedo Fluoride Treatment | Cao Group, Inc.
    No Recall

    Sheer Fluorx Pedo Fluoride Treatment | Cao Group, Inc.

    Sheer Fluorx Pedo Fluoride Treatment | Cao Group, Inc.
    Use enclosed EZ opener to cut wrapper open.
    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. You may use scissors to trim film to desired size.
    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. 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.
    Leave the film in place for 15-60 minutes. DO NOT wear for more than 60 minutes in a 24 hour period. To remove, grasp corner of film and begin to loosen away from teeth. Rinsing with water may help.
    Continue removing film from all surfaces. The film may come away in pieces; this is normal. Avoid swallowing gel, rinse to sink.
    Brush teeth and gums to remove any remaining gel. Rinse to sink, avoid swallowing excess gel.