cut Ultra Control Generic Name: sodium fluoride Dosage Form: dental aerosol, foam Side Effects Dosage Professional Pregnancy Reviews More Support Group Q & A 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. Indications: For the topical application of fluoride to aid in the protection against dental caries. Contraindications: This product should not be used with individuals with known sensitivities to fluoride. Directions for Use: 1. Remove cap from can. 2. The first time you dispense from a new can, gently lift upward on the nozzle to break the protective shipping tab (Fig. 1). 3. Shake can vigorously for at least 10 seconds before each use. 4. Hold can completely upside down to dispense (Fig. 2). 5. Point can towards applicator tray and slowly press the nozzle to fill tray. Use one press per arch, as foam will expand slightly to fill the tray. 6. For best results, dry teeth prior to application. 7. Insert the filled tray and have the patient bite down lightly, with a chewing motion to ensure interproximal coverage. 8. Leave tray(s) in contact with teeth for 1 to 4 minutes. 9. Use a saliva ejector during treatment to minimize ingestion of product. 10. Remove tray(s) and have patient expectorate. 11. Instruct patient not to eat, drink, or rinse for at least 30 minutes after application. Contains: 1.23% Fluoride ion from sodium fluoride in a proprietary acidulated phosphate flavored foam base. Does not contain chlorofluorocarbon propellant. Sweetened with Xylitol (sucralose). Does not contain Aspartame or Saccharin. Gluten free. Precautions: Use only as directed. For dental use only. U.S. Federal Law prohibits dispensing without prescription. Not for unsupervised home use. Safety and efficacy in patients under the age of 3 has not been established. Repeated use of APF formulations in patients with porcelain or composite restorations should be avoided due to the possibility of etching the restoration surface. Warning: Do not swallow. Keep out of reach of children. Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate. Ultra Control MINT sodium fluoride aerosol, foam Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75905-003 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.23 g in 100 g Inactive Ingredients Ingredient Name Strength WATER SUCRALOSE XYLITOL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BETAINE POLOXAMER 407 Packaging # Item Code Package Description 1 NDC:75905-003-14 125 g in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/20/2011 Labeler - WATER PIK, INC. (001804074) Registrant - WATER PIK, INC. (001804074) Revised: 12/2013 WATER PIK, INC. Next Pregnancy Warnings Print this page Add to My Med List More about Ultra Control (fluoride topical) Side Effects During Pregnancy Dosage Information Support Group 0 Reviews Add your own review/rating Consumer resources Professional resources Stannous Fluoride Oral Rinse (FDA) Other brands: Prevident 5000 Plus , Fluoridex , SF 5000 Plus , Clinpro 5000 , ... +52 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 Related Drugs Prevention of Dental Caries Biotene , Prevident , fluoride , Prevident 5000 Plus , Denta 5000 Plus , SF , SF 5000 Plus , Fluoridex , Clinpro 5000 , Dentagel , PreviDent 5000 Booster , Gelato X , Prevident 5000 Sensitive , Zooby , ACT Fluoride Rinse , Neutral Sodium Fluoride Rinse , Flura-Drops , Prevident Mouthwash , Perio Med , Colgate Total Advanced Clean , Luride , More... Ultra Control Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! transport
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