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Name:Fluoridemelon
Manufacturer:Water Pik, Inc.
Category:Prescription Marketed Drugs


WATER PIK FLUORIDE FOAM MELON

FLUORIDE MELON - 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.

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WATER PIK FLUORIDE FOAM MELON

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.

WATERPIK
Ultra Control
Fluoride Foam
Melon

Precise foaming action
Sweetened with Xylitol
Gluten free

*Acidulated Phosphate Fluoride
1.23% Fluoride Ion (pH 3.5)

For professional use only.
Store at room temperature
between 55°–80°F.
Shake well before each use.

To obtain a MSDS sheet, please
call Water Pik, Inc. customer
service at 1-800-525-2020.
Made in the U.S.A.
Distributed by:
Water Pik, Inc.
1730 E. Prospect Road
Fort Collins, CO 80553-0001
1-800-525-2020
www.waterpik.com
Waterpik® (stylized) is a
trademark of Water Pik, Inc.
registered Canada, EU, Japan,
Mexico, Switzerland, and the
United States.
©2011 Water Pik, Inc.
Water Pik Item Number:
20014143
FN 20014519-F AA
373485
UltraControl Foam ART Melon-Carton_BK
UltraControl Foam ART Melon-Carton_FR

UltraControl Foam ART Melon-LBL


FLUORIDE  MELON
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75905-002
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  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75905-002-24 1 CAN ( CAN) in 1 BOX contains a CAN (75905-002-14)
1 NDC:75905-002-14 125 g in 1 CAN This package is contained within the BOX (75905-002-24)

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, analysis

Revised: 05/2011 WATER PIK, INC.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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