60 SECOND TASTE ORANGE TWIST- 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.

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60 Second Taste Orange Twist

Contains:

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

Contraindicated in individuals who are hypersensitive to fluoride.

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

Not for system 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 aritifical 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 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 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.

60 Second Taste Bottle 081460 Second Taste Orange Flavor Label 0410

60 Second Taste Gel

Anticavity Topical APF*

Preventive Treatment Gel

*Acidulated Phosphate Fluoride

Orange Twist

60 SECOND TASTE ORANGE TWIST 
topical apf fluoride gel gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0485
Route of AdministrationBUCCAL, DENTAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION27.73 mg  in 1 g
Product Characteristics
ColororangeScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10866-0485-2480 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/01/1993
Labeler - Pascal Company, Inc. (009260217)
Establishment
NameAddressID/FEIBusiness Operations
Pascal Company, Inc.009260217manufacture(10866-0485)

Revised: 5/2015
Document Id: 15faabc3-34fc-2565-e054-00144ff8d46c
Set id: 15faabc3-34fb-2565-e054-00144ff8d46c
Version: 1
Effective Time: 20150513
 
Pascal Company, Inc.