Label: 60 SECOND TASTE CHOCOLATE VANILLA- topical apf fluoride gel gel
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Updated March 30, 2015
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- PRINCIPAL DISPLAY PANEL
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.
- 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 Safey Information
INGREDIENTS AND APPEARANCE
60 SECOND TASTE CHOCOLATE VANILLA
topical apf fluoride gel gel
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10866-0885 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 27.73 mg in 1 g Inactive Ingredients Ingredient Name Strength Saccharin Sodium (UNII: SB8ZUX40TY) 5.5 mg in 1 g Product Characteristics Color white Score Shape Size Flavor CHOCOLATE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10866-0885-2 480 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/15/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/15/2007 Labeler - Pascal Company, Inc. (009260217) Establishment Name Address ID/FEI Business Operations Pascal Company, Inc. 009260217 manufacture(10866-0885)