Pro-den Rx
FDA Label NDC 59883-168

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zila Therapeutics, Inc. for the product Pro-den Rx (NDC 59883-168). 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 otc - active ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Sodium Fluoride 0.044% w/w (0.02% w/v fluoride ion)

Otc - Purpose

Anticavity

Approved Uses

  • Aids in prevention of dental caries (cavities).
  • The combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.

    • Warnings

    • Please keep out of reach of children.
    • If more than used for rinsing is accidentally swallowed get medical help or contact a Poison Control Center right away. Use only under guidance or supervision of a dentist or doctor.

      • Directions: This is a fluoride treatment rinse, not a mouthwash.  Read directions carefully before using.

      Adults and Children
      6 yrs and older
                                                        		Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 ml of rinse between your teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
      Children 6 to 12
                                                                		Instruct and supervise in good rinsing (to minimize swallowing).
      Children Under 6
      		Consult a dentist or doctor.

      Inactive Ingredients:

      Distilled water, monosodium phosphate, sodium benzoate, sodium saccharin, artificial color, artificial flavor.

      Made for and Distributed in US by:
      Zila Therapeutics, Inc.,

      P.O. Box 3889, Batesville, AR 72503

      1-800-228-5595

* Please review the disclaimer below.