PH7 GEL MINT- topical neutral 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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pH7 Anticavity Topical Neutral Fluoride Preventive Treatment Gel

Mint

Bottle Label

Mint Flavor label

Contains:

Active Ingredient: Sodium Fluoride 2.0% w/w /0.9% fluoride ion

Indications

Professionally applied dental caries preventive.

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.

Dosage and Directions for Use

Usual dosage is approximately 2.75-9.0 grams of pH7 Gel per dual arch treatment depending on tray size

  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 Safety Information

For product MSDS information please see company website at pascaldental.com or contact Pascal directly.

pH7 Gel is free of gluten, soy, milk, egg, peanut and tree nut products.

Rx Only in USA For Professional Use only.

PH7 GEL MINT 
topical neutral fluoride gel gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0093
Route of AdministrationTOPICAL, BUCCAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion9.05 mg  in 1 g
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10866-0093-1473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/1993
Labeler - Pascal Company, Inc. (009260217)
Establishment
NameAddressID/FEIBusiness Operations
Pascal Company, Inc.009260217manufacture(10866-0093)

Revised: 3/2015
Document Id: 12360727-2599-3365-e054-00144ff88e88
Set id: 12360727-2598-3365-e054-00144ff88e88
Version: 1
Effective Time: 20150326
 
Pascal Company, Inc.