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ULTRA CONTROL

WATER PIK, INC.
WATER PIK, INC.




FULL PRESCRIBING INFORMATION

Uses

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.

ULTRA CONTROL

ULTRA CONTROL

ULTRA CONTROL

ULTRA CONTROL

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 1.23 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:75905-001-14 125 in 1 CAN
2 NDC:75905-001-24 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-06


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