Label: 60 SECOND TASTE CHOCOLATE VANILLA- topical apf fluoride gel gel


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 March 30, 2015

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    60 Second Taste Gel

    Anticavity Topical APF*

    Preventive Treatment Gel

    *Acidulated Phosphate Fluoride

    Chocoloate Vanilla

    60 Second Taste Bottle

    Chocolate Vanilla Flavor Label

  • Contains:

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

  • Contraindications

    Contraindicated in individuals who are hypersensitive to fluoride

  • Warnings and Precautions

    Keep out of reach of children. For topical intraoral use only. For professionally applied in office fluoride treatment only.

    Not for systemic treatement. Do no swallow.

    Do not use on patients with an allergy to fluoride.

    60 Second Taste contains artifical 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 abraided or sensitive oral tissue may produce discomfort.

    If more than is ordinarily used for treatment is swallowed, administer calcium such as milk and contact your local Poison Control Center immediately.

  • Dosage and Directions for Use:

    Usual dosage is approximately 2.75-9.0 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 have become frozen, warm to room temperature and shake well before using.

  • Other Safey Information

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

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

    Rx only in USA. For Professional Use only.

    topical apf fluoride gel gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0885
    Route of AdministrationTOPICAL, DENTAL, BUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Fluoride ion27.73 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Saccharin Sodium (UNII: SB8ZUX40TY) 5.5 mg  in 1 g
    Product Characteristics
    FlavorCHOCOLATEImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10866-0885-2480 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/15/2007
    Labeler - Pascal Company, Inc. (009260217)
    NameAddressID/FEIBusiness Operations
    Pascal Company, Inc.009260217manufacture(10866-0885)