Label: 60 SECOND TASTE MARSHMALLOW- topical apf fluoride gel gel

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

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.

Drug Label Information

Updated April 16, 2015

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

  • DOSAGE FORMS & STRENGTHS

    Contains: Active Ingredient: 1.23% w/w fluoride ion from 2.72% sodium fluoride

    Indications for Use: Professionally applied dental caries preventive.

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  • CONTRAINDICATIONS

    Contraindications: Contraindicated in individuals who are hypersensitive to fluoride.

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  • WARNINGS AND PRECAUTIONS

    Warning: Keep out of reach of children. For topical intraoral use only. For professionally applied, in-office treatment only.

    Precautions:

    • Not for systemic treatment. Do not swallow.
    • Do not use on patients with an allergy to fluoride.
    • 60 Second Taste contains artificial color and flavor; confirm that no known patient allergies exist (Marshmallow and Chocolate Vanilla are Dye-Free and contain no artificial colors.
    • Special care should be used when administering to children under 6 years of age so that gel is not swallowed.
    • Contact with abraded or sensitive oral tissue may produce discomfort.
    • If moren than is ordinarily used for treatment is swallowed, administer calcium (milk) and contact your local Poison Control Center immediately.
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  • DOSAGE & ADMINISTRATION

    Dosage and Directions for Use:

    Usual dosage is approximately 2.75-9 grams of 60 Second Taste per dual arch treatment (depending on tray size).

    SHAKE WELL BEFORE USE

    1. After prophylaxis remove excess fluid from teeth.
    2. Fill applicator tray 1/3 full with gel.
    3. Insert filled tray into patient's mouth and instruct to bite down gently for one minute or up to four minutes.
    4. After treatment time is completed remove tray and have patient expectorate residual gel.
    5. For maximum benefits for the prevention of caries, instruct patient not to rinse, eat or drink for 30 minutes.

    Repeat treatment at least once or twice a year. For patients with rampant or active caries, repeat treatment once or twice every six months.

    If contents become frozen, warm to room temperature and shake well before using.

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  • OTHER SAFETY INFORMATION

    For product MSDS information, please see company website at pascaldental.com or contact Pascal directly.

    Pascal's 60 Second Taste is free of gluten, soy, milk, egg, peanut and tree nut products.

    Rx Only (in USA). For Professional Use Only.

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  • PRINCIPAL DISPLAY PANEL

    60 Second Taste Gel

    Anticavity Topical APF*

    Preventive Treatment Gel

    *Acidulated Phosphate Fluoride

    Bottle

    Flavor label

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  • INGREDIENTS AND APPEARANCE
    60 SECOND TASTE MARSHMALLOW 
    topical apf fluoride gel gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10866-0785
    Route of Administration TOPICAL, BUCCAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 27.73 mg  in 1 g
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor MARSHMALLOW Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10866-0785-2 480 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/1988
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/01/1988
    Labeler - Pascal Company, Inc. (009260217)
    Establishment
    Name Address ID/FEI Business Operations
    Pascal Company, Inc. 009260217 manufacture(10866-0785)
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