Label: ULTRA CONTROL STRAWBERRY- sodium fluoride aerosol, foam 

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 12/13

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    Indications: For the topical application of fluoride to aid in the protection against dental caries.

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  • CONTRAINDICATIONS

    Contraindications: This product should not be used with individuals with known sensitivities to fluoride.

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  • DOSAGE & ADMINISTRATION

    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.

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  • DOSAGE FORMS & STRENGTHS

    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.

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  • PRECAUTIONS

    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.

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  • WARNINGS

    Warning:


    Do not swallow.
    Keep out of reach of children.
    Avoid spraying toward open flame.
    Contents under pressure.
    Do not puncture or incinerate.

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  • INGREDIENTS AND APPEARANCE
    ULTRA CONTROL  STRAWBERRY
    sodium fluoride aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75905-004
    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 Marketing Start Date Marketing End Date
    1 NDC:75905-004-14 125 g in 1 CAN
    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)
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