60 SECOND TASTE GROOVY GRAPE- topical apf fluoride gel gel

60 Second Taste Groovy Grape by

Drug Labeling and Warnings

60 Second Taste Groovy Grape by is a Prescription medication manufactured, distributed, or labeled by Pascal Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

60 Second Taste Gel

Anticavity Topical APF*

Preventive Treatment Gel

*Acidulated Phosphate Fluoride

Groovy Grape

Contains:

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

Contraindications

Contraindicated in individuals who are hypersensitive to fluoride.

Warnings and Precautions

Keep out of reach of children. for topical intraoral use only. For professionally applied, in-office fluoride treatments only.

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 abraided 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 2.75-9.0 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 paitnet 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 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.

INGREDIENTS AND APPEARANCE

60 SECOND TASTE GROOVY GRAPE 
topical apf fluoride gel gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10866-0285
Route of Administration	BUCCAL, DENTAL, TOPICAL

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	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10866-0285-2	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(10866-0285)