RxNorm Names
Review RxNorm Normal Forms
WATER PIK ULTRA CONTROL FLUORIDE BUBBLEGUM
(sodium fluoride)
aerosol, foam
[WATER PIK, INC.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9cebf90c-d26e-435d-9949-5375e3d41342| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN PRESCRIPTION DRUG LABEL | unapproved drug other |
NOTE: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.
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.
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.
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.
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.
| WATER PIK ULTRA CONTROL FLUORIDE
BUBBLEGUM
sodium fluoride aerosol, foam |
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| 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) | |
Revised: 12/2012
Document Id: 2746127d-77f1-404c-b12e-49cf4ffeeef1
Set id: 9cebf90c-d26e-435d-9949-5375e3d41342
Version: 10
Effective Time: 20121204
WATER PIK, INC.
