60 SECOND TASTE MARSHMALLOW- 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 Marshmallow

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

Indications for Use: Professionally applied dental caries preventive.

Contraindications: Contraindicated in individuals who are hypersensitive to fluoride.

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

Precautions:

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 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 Gel

Anticavity Topical APF*

Preventive Treatment Gel

*Acidulated Phosphate Fluoride

Bottle

Flavor label

60 SECOND TASTE MARSHMALLOW 
topical apf fluoride gel gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0785
Route of AdministrationTOPICAL, BUCCAL, DENTAL
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
ColorwhiteScore    
ShapeSize
FlavorMARSHMALLOWImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10866-0785-2480 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/1988
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/1988
Labeler - Pascal Company, Inc. (009260217)
Establishment
NameAddressID/FEIBusiness Operations
Pascal Company, Inc.009260217manufacture(10866-0785)

Revised: 4/2015
Document Id: 129c407b-49ed-3152-e054-00144ff8d46c
Set id: 129c407b-49ec-3152-e054-00144ff8d46c
Version: 1
Effective Time: 20150416
 
Pascal Company, Inc.