60 Second Taste Groovy Grape

60 SECOND TASTE GROOVY GRAPE- sodium fluoride gel
Pascal Company, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

60 Second Taste Gel

Anticavity Topical APF*

Preventive Treatment Gel

*Acidulated Phosphate Fluoride

Groovy Grape

60 Second Taste Bottle
(click image for full-size original)
Groovy Grape Flavor Label
(click image for full-size original)

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.

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.

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium fluoride (Fluoride Ion) 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 Multilevel Packaging
1 NDC:10866-0285-2 480 g in 1 BOTTLE, PLASTIC None
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 Operations
Pascal Company, Inc. 009260217 manufacture (10866-0285)

Revised: 03/2015 Pascal Company, Inc.

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