WATER PIK ULTRA CONTROL FLUORIDE BUBBLEGUM

WATER PIK ULTRA CONTROL FLUORIDE BUBBLEGUM- sodium fluoride aerosol, foam
WATER PIK, INC.

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.

UltraControl Foam ART Bubblegum-Carton_BK
(click image for full-size original)

UltraControl Foam ART Bubblegum-Carton_FR
(click image for full-size original)
UltraControl Foam ART Bubblegum-LBL
(click image for full-size original)
WATER PIK ULTRA CONTROL FLUORIDE BUBBLEGUM sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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 Multilevel Packaging
1 NDC:75905-001-24 1 CAN (CAN) in 1 BOX contains a CAN (75905-001-14)
1 NDC:75905-001-14 125 g in 1 CAN This package is contained within the BOX (75905-001-24)
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 Operations
Medical Products Laboratories, Inc. 002290302 manufacture (75905-001), analysis (75905-001)

Revised: 12/2012 WATER PIK, INC.


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