options Sheerfluorx FluorideTreatment Generic Name: sodium fluoride Dosage Form: dental film Overview Side Effects Dosage Professional Pregnancy More User Reviews Drug Images Support Group Q & A Compare Alternatives Pricing & Coupons 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 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. 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. Next Pregnancy Warnings Print this page Add to My Med List More about fluoride topical Side Effects During Pregnancy Dosage Information Drug Images Compare Alternatives Support Group Pricing & Coupons En Español 9 Reviews Add your own review/rating Drug class: minerals and electrolytes Consumer resources Fluoride topical ... +5 more Professional resources Fluoride Foam (FDA) Sodium Fluoride Dental Rinse (FDA) Stannous Fluoride Oral Rinse (FDA) Fluoride (Wolters Kluwer) Other brands: Prevident 5000 Plus , SF 5000 Plus , Fluoridex , Clinpro 5000 , ... +53 more Related treatment guides Prevention of Dental Caries FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Minerals and electrolytes Related Drugs minerals and electrolytes potassium chloride , calcium carbonate , Caltrate , magnesium oxide , Klor-Con , sodium chloride Prevention of Dental Caries Biotene , Prevident , fluoride topical , Prevident 5000 Plus , Denta 5000 Plus , SF , SF 5000 Plus , Fluoridex , Clinpro 5000 , Dentagel , Gelato X , Prevident 5000 Sensitive , PreviDent 5000 Booster , Zooby , Flura-Drops , Prevident Mouthwash , Perio Med , ACT Fluoride Rinse , Neutral Sodium Fluoride Rinse , Denti-Care Denti-Pro , More... Fluoride topical Rating 9 User Reviews 7.8 /10 9 User Reviews 7.8 Rate it! Fluoride topical Images Fluoride topical 0.25 mg (432 ETH) View all images most opulent
recommendations Sheerfluorx FluorideTreatment really fizzling out
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