Package Label.Principal Display Panel
pH7 Anticavity Topical Neutral Fluoride Preventive Treatment Gel
Mint
Ph7 Gel Mint
FDA Label NDC 10866-0093
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pascal Company, Inc. for the product Ph7 Gel Mint (NDC 10866-0093). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding package label.principal display panel, contains:, indications, contraindications, warnings and precautions, dosage and directions for use, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- After prophylaxis remove excess fluid from teeth.
- Fill applicator tray 1/3 full with gel.
- Insert filled tray into patient's mouth and instruct to bite down gently for one minute or up to four minutes.
- After treatment time is completed remove tray and have patient expectorate residual gel.
- 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.
* Please review the disclaimer below.
