60 SECOND TASTE GROOVY GRAPE (TOPICAL APF FLUORIDE GEL) GEL [PASCAL COMPANY, INC.]

60 SECOND TASTE GROOVY GRAPE (TOPICAL APF FLUORIDE GEL) GEL [PASCAL COMPANY, INC.]
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NDC 10866-0285-2
Set ID 129a945b-a006-5bb1-e054-00144ff88e88
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Pascal Company, Inc.
Generic Name
Product Class
Product Number
Application Number
  • PRINCIPAL DISPLAY PANEL

    60 Second Taste Gel

    Anticavity Topical APF*

    Preventive Treatment Gel

    *Acidulated Phosphate Fluoride

    Groovy Grape

    60 Second Taste Bottle

    Groovy Grape 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 treatments only.

    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 abraided or sensitive oral tissue may produce discomfort.

    If more than is ordinarily used for treatment is swallowed, administer calcium (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 paitnet 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 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.

  • INGREDIENTS AND APPEARANCE
    60 SECOND TASTE GROOVY GRAPE 
    topical apf fluoride gel gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0285
    Route of AdministrationBUCCAL, DENTAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion27.73 mg  in 1 g
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10866-0285-2480 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/1988
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/1988
    Labeler - Pascal Company, Inc. (009260217)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pascal Company, Inc.009260217manufacture(10866-0285)

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