Label: 60 SECOND TASTE MARSHMALLOW- topical apf fluoride gel gel
- NDC Code(s): 10866-0785-2
- Packager: Pascal Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated April 16, 2015
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- DOSAGE FORMS & STRENGTHS
WARNINGS AND PRECAUTIONS
Warning: Keep out of reach of children. For topical intraoral use only. For professionally applied, in-office treatment 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 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.
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
- 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 become frozen, warm to room temperature and shake well before using.
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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)