Dosage Forms & Strengths
Contains: Active Ingredient: 1.23% w/w fluoride ion from 2.72% sodium fluoride
Indications for Use: Professionally applied dental caries preventive.
60 Second Taste Marshmallow
FDA Label NDC 10866-0785
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 Marshmallow (NDC 10866-0785). 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 dosage forms & strengths, contraindications, warnings and precautions, dosage & administration, other safety information, 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
Contraindications: Contraindicated in individuals who are hypersensitive to fluoride.
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
For product MSDS information, please see company website at pascaldental.com or contact Pascal directly.
Pascal's 60 Second Taste is free of gluten, soy, milk, egg, peanut and tree nut products.
Rx Only (in USA). For Professional Use Only.
Package Label.Principal Display Panel
60 Second Taste Gel
Anticavity Topical APF*
Preventive Treatment Gel
*Acidulated Phosphate Fluoride
* Please review the disclaimer below.
