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Ph7 Gel Mint (Gelato sodium fluoride) Package Insert

Status:
Prescription (Rx) Facts
Strength:
9.05 mg/g
Brand names:
Active ingredient:

Prescribing information (package insert) - Ph7 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. 1. After prophylaxis remove excess fluid from teeth.
  2. 2. Fill applicator tray 1/3 full with gel.
  3. 3. Insert filled tray into patient's mouth and instruct to bite down gently for one minute or up to four minutes.
  4. 4. After treatment time is completed remove tray and have patient expectorate residual gel.
  5. 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.

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Ph7 Gel Mint

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Sodium fluoride 9.05 mg/g
Dosage form Gel
Route Buccal, Dental, Topical
Marketing status not in the current FDA NDC Directory
Company (applicant) Pascal Company, Inc.
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
9.05 mg/g – 473 g in 1 bottle, plastic NDC 10866-0093-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.