Contains:
Active Ingredient: 1.23% w/w fluoride ion from 2.72% sodium fluoride
60 Second Taste Orange Twist
FDA Label NDC 10866-0485
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pascal Company, Inc. for the product 60 Second Taste Orange Twist (NDC 10866-0485). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding contains:, contraindications, warnings and precautions, dosage and directions for use:, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Contraindications
Contraindicated in individuals who are hypersensitive to fluoride.
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 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 aritifical 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 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 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.
Package Label.Principal Display Panel
60 Second Taste Gel
Anticavity Topical APF*
Preventive Treatment Gel
*Acidulated Phosphate Fluoride
Orange Twist
* Please review the disclaimer below.
