1. Home
  2. Labeler Index
  3. Zila Therapeutics, Inc.
  4. 59883-168
  5. Label Information: Pro-den Rx

FDA Label for Pro-den Rx

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE

Pro-den Rx Product Label

The following document was submitted to the FDA by the labeler of this product Zila Therapeutics, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.