Label: ULTRA CONTROL BUBBLEGUM- sodium fluoride aerosol, foam
- NDC Code(s): 75905-001-14, 75905-001-24
- Packager: WATER PIK, INC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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- INDICATIONS & USAGE
Indications: For the topical application of fluoride to aid in the protection against dental caries.Close
Contraindications: This product should not be used withClose
individuals with known sensitivities to fluoride.
- DOSAGE & ADMINISTRATION
Directions for Use:Close
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.
- DOSAGE FORMS & STRENGTHS
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.
- 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.
- Do not swallow.
- Keep out of reach of children.
- Avoid spraying toward open flame.
- Contents under pressure.
- Do not puncture or incinerate.
- INGREDIENTS AND APPEARANCE
ULTRA CONTROL BUBBLEGUM
sodium fluoride aerosol, foam
Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75905-001 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 Marketing Start Date Marketing End Date 1 NDC:75905-001-24 1 in 1 BOX 1 NDC:75905-001-14 125 g in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/06/2011 Labeler - WATER PIK, INC. (001804074) Registrant - WATER PIK, INC. (001804074) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories, Inc. 002290302 manufacture(75905-001), analysis(75905-001)