Label: 60 SECOND TASTE MARSHMALLOW- topical apf fluoride gel gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 10866-0785-2 - Packager: Pascal Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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 April 16, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE FORMS & STRENGTHS
- CONTRAINDICATIONS
-
WARNINGS AND PRECAUTIONS
Warning: Keep out of reach of children. For topical intraoral use only. For professionally applied, in-office treatment only.
Precautions:
- 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 gelProduct 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)
