Water PIK Fluoride

Generic Name: sodium fluoride

Dosage Form: aerosol, foam
Water PIK Fluoride FOAM MINT 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

MINT


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

FLUORIDE  MINT sodium fluoride  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 75905-003-14 125 g In 1 CAN None

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)

Establishment
Name	Address	ID/FEI	Operations
Medical Products Laboratories, Inc.		002290302	manufacture, analysis

Revised: 07/2011WATER PIK, INC.