FDA.reportPublic FDA data

60 Second Taste Marshmallow

Manufacturer
Pascal Company, Inc.
Effective date
2015-04-16
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:20:41

Label at a glance#

Product60 Second Taste Marshmallow
Active ingredientSodium fluoride
Label structure6 sections

Label contents#

Full prescribing information#

DOSAGE FORMS & STRENGTHS SECTION

Contains: Active Ingredient: 1.23% w/w fluoride ion from 2.72% sodium fluoride

Indications for Use: Professionally applied dental caries preventive.

CONTRAINDICATIONS SECTION

Contraindications: Contraindicated in individuals who are hypersensitive to fluoride.

WARNINGS AND PRECAUTIONS SECTION

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 SECTION

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

  1. After prophylaxis remove excess fluid from teeth.
  2. Fill applicator tray 1/3 full with gel.
  3. Insert filled tray into patient's mouth and instruct to bite down gently for one minute or up to four minutes.
  4. After treatment time is completed remove tray and have patient expectorate residual gel.
  5. 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

BottleBottle

Flavor labelFlavor label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1535362sodium fluoride 2.72 % Oral GelPSN1
1535362sodium fluoride 0.0272 MG/MG Oral GelSCD1
1535362sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10866-0785-22020-01-31C16284748780-19d75b9d1-201c-f424-e053-dadaa90a57ce60 Second Taste Marshmallow

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10866-0785-260 Second Taste Marshmallow480 g in 1 BOTTLE, PLASTICGEL4801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10866-078560 SECOND TASTE MARSHMALLOW (TOPICAL APF FLUORIDE GEL) GEL [PASCAL COMPANY, INC.]1Legacy NDC, 1 package rows20150416_129c407b-49ec-3152-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium fluorideACTIVE INGREDIENT8ZYQ1474W71
Fluoride IonACTIVE MOIETYQ80VPU408O1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10866-078510866-0785-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium fluoride8ZYQ1474W7ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
129c407b-49ed-3152-e054-00144ff8d46c129c407b-49ec-3152-e054-00144ff8d46c2015-04-16WarningsExact identifier
spl id: 129c407b-49ed-3152-e054-00144ff8d46c
spl set id: 129c407b-49ec-3152-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.