60 SECOND TASTE CHOCOLATE VANILLA- topical apf fluoride gel 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

Chocoloate Vanilla

60 Second Taste Bottle

Chocolate Vanilla Flavor Label

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 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:

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

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.

60 SECOND TASTE CHOCOLATE VANILLA 
topical apf fluoride gel gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0885
Route of AdministrationTOPICAL, DENTAL, BUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Fluoride ion27.73 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Saccharin Sodium (UNII: SB8ZUX40TY) 5.5 mg  in 1 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorCHOCOLATEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10866-0885-2480 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/15/2007
Labeler - Pascal Company, Inc. (009260217)
Establishment
NameAddressID/FEIBusiness Operations
Pascal Company, Inc.009260217manufacture(10866-0885)

Revised: 3/2015
Document Id: 1287d2cd-9109-10cf-e054-00144ff88e88
Set id: 1287d2cd-9108-10cf-e054-00144ff88e88
Version: 1
Effective Time: 20150330
 
Pascal Company, Inc.