- Indications for Use
- Contraindications
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Warnings and Precautions
Keep out or reach of children. For topical intraoral use only. For professionally applied, in office fluoride treatment only.
Not for system treatment. Do no 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 aritifical 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 in ordinarily used for treatment is swallowed, administer calcium such as milk and contact your local Poison Control Center immediately.
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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
- After prophylaxis remove excess fluid from teeth.
- Fill applicator tray 1/3 full with gel.
- Insert filled tray into patient's mouth and instruct to bite down gently for one minute, or up to four minutes.
- After treatment time is completed, remove tray and have patient expectorate residual gel.
- 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 SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
60 SECOND TASTE BUBBLEGUM
topical apf fluoride gel gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10866-0185 Route of Administration TOPICAL, DENTAL, BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 12.3 mg in 1 g Product Characteristics Color pink Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10866-0185-2 480 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(10866-0185)