Your browser does not support JavaScript! ULTRA CONTROL BUBBLEGUM (SODIUM FLUORIDE) AEROSOL, FOAM [WATER PIK, INC.]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

ULTRA CONTROL BUBBLEGUM (sodium fluoride) aerosol, foam
[WATER PIK, INC.]


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.
Drug Label Sections

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

UltraControl Foam ART Bubblegum-Carton_FR

UltraControl Foam ART Bubblegum-LBL

ULTRA CONTROL  BUBBLEGUM
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:75905-001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.23 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SUCRALOSE 
XYLITOL 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
BETAINE 
POLOXAMER 407 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75905-001-241 in 1 BOX
1NDC:75905-001-14125 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/06/2011
Labeler - WATER PIK, INC. (001804074)
Registrant - WATER PIK, INC. (001804074)
Establishment
NameAddressID/FEIBusiness Operations
Medical Products Laboratories, Inc.002290302manufacture(75905-001), analysis(75905-001)

Revised: 12/2013
 
WATER PIK, INC.

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services