PH7 GEL MINT- topical neutral fluoride gel gel

pH7 Gel Mint by

Drug Labeling and Warnings

pH7 Gel Mint by is a Prescription medication manufactured, distributed, or labeled by Pascal Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

pH7 Anticavity Topical Neutral Fluoride Preventive Treatment Gel

Mint

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.

• Not for systemic treatement. Do not swallow.
• Do not use on patients with an allergy to fluoride
• pH7 Gel contains artificial flavor and color; confirm that no known patient allergies exist.
• 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, adminster 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 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.

INGREDIENTS AND APPEARANCE

PH7 GEL MINT 
topical neutral fluoride gel gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10866-0093
Route of Administration	TOPICAL, BUCCAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	9.05 mg  in 1 g

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10866-0093-1	473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/1993

Labeler - Pascal Company, Inc. (009260217)

Establishment
Name	Address	ID/FEI	Business Operations
Pascal Company, Inc.		009260217	manufacture(10866-0093)