60 Second Taste Chocolate Vanilla

Manufacturer
Pascal Company, Inc.
Effective date
2015-03-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:20:37

Label at a glance#

Product60 Second Taste Chocolate Vanilla
Active ingredientSodium fluoride
Label structure6 sections

Dosage and administration

Usual dosage is approximately 2.75-9.0 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 resid...

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 Second Taste Gel

Anticavity Topical APF*

Preventive Treatment Gel

*Acidulated Phosphate Fluoride

Chocoloate Vanilla

60 Second Taste Bottle60 Second Taste Bottle

Chocolate Vanilla Flavor LabelChocolate Vanilla Flavor Label

Contains:

DOSAGE FORMS & STRENGTHS SECTION

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

Contraindications

CONTRAINDICATIONS SECTION

Contraindicated in individuals who are hypersensitive to fluoride

Warnings and Precautions

WARNINGS AND PRECAUTIONS SECTION

Keep out of reach of children. For topical intraoral use only. For professionally applied in office fluoride treatment only.

Not for systemic treatement. Do no swallow.

Do not use on patients with an allergy to fluoride.

60 Second Taste contains artifical 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 abraided or sensitive oral tissue may produce discomfort.

If more than is ordinarily used for treatment is swallowed, administer calcium such as milk and contact your local Poison Control Center immediately.

Dosage and Directions for Use:

DOSAGE & ADMINISTRATION SECTION

Usual dosage is approximately 2.75-9.0 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 have become frozen, warm to room temperature and shake well before using.

Other Safey Information

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 gluten, soy, milk, egg, peanut and tree nut products.

Rx only in USA. For Professional Use only.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10866-0885-22020-01-31C16284748780-19d75b9d0-5ae5-f424-e053-dadaa90a57ce1287d2cd-9108-10cf-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10866-0885-260 Second Taste Chocolate Vanilla480 g in 1 BOTTLE, PLASTICGEL4801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10866-088560 SECOND TASTE CHOCOLATE VANILLA (TOPICAL APF FLUORIDE GEL) GEL [PASCAL COMPANY, INC.]1Legacy NDC, 1 package rows20150331_1287d2cd-9108-10cf-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium fluorideACTIVE INGREDIENT8ZYQ1474W71
Fluoride ionACTIVE MOIETYQ80VPU408O1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10866-088510866-0885-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Saccharin SodiumSB8ZUX40TYIACT
Sodium fluoride8ZYQ1474W7ACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 34 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYOINTMENT / DENTALNAExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / BUCCAL0.4 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / RECTAL0.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SUSPENSION / ORAL85 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates

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
1287d2cd-9109-10cf-e054-00144ff88e881287d2cd-9108-10cf-e054-00144ff88e882015-03-30WarningsExact identifier
spl id: 1287d2cd-9109-10cf-e054-00144ff88e88
spl set id: 1287d2cd-9108-10cf-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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