Pro-Den Rx

Zila Therapeutics, Inc.

Pro-Den Rx 0.2%

FULL PRESCRIBING INFORMATION

Sodium Fluoride Dye Free Rinse

ProDenRx Neutral Sodium Fluoride is a neutral, aqueous solution.

Sodium Fluoride 0.2% w/w (0.09% w/w fluoride ion).

Purified water, citric acid, potassium sorbate, sucralose and flavor.

Clinical Pharmacology: Sodium fluoride when used topically promotes remineralization, increases resistance of teeth to acid dissolution, and impedes the cariogenic microbial process.

A self-applied homecare fluoride rinse for topical use to aid in the protection against dental caries.  Using a neutral 0.2% sodium fluoride solution on a weekly basis guards against dental caries in children. ^1-4  May be used more than once a week is recommended by your dentist.  Pro-DenRx Rinse is ready to use, convenient and thus increases compliance.

Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in adults and children.  May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.

Do not use in children under 6 years unless recommended by a dentist or physician.

PLEASE KEEP OUT OF THE REACH OF CHILDREN.  READ DIRECTIONS CAREFULLY BEFORE USING.

Precautions: General:  Not for systemic treatment.  DO NOT SWALLOW.

Adverse Reactions: NONE

Overdosage: Swallowing a normal treatment dose (approximately 9 mg. of fluoride is not harmful) is not harmful.

Adults and children over age 6 years:  Rinse once a week, preferably at bedtime, after thoroughly brushing and flossing teeth.  Rinse more often if your dentist recommends additional therapy based on your diagnosis.  Pour 10 ml (2 teaspoons) of ProDenRx 0.2% Sodium Fluoride Rinse into the graduated cup using the markings on its side.  Swish vigorously around and between the teeth for one minute, then spit out.  DO NOT SWALLOW.  For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after use.  Children 6 to 12 years old: Supervise while using this product.  Children Under 6 years old:  Consult your dentist or doctor before using.

For home use:  Plastic bottle containing 16 fl. oz. (473 ml)

Cool Mint: NDC 59883-920-16
Berry Fresh: NDC 59883-922-16

Rx only:

Storage: Store at Room Temperature

References:

• 1.  Accepted Dental Therapeutics, Ed. 40, Chicago (1984).
  2.  Ibid, p. 405-407.
  3.  L.W.Ripa, G.S.Leske, and A. Sposato, J.Pub. ealth Dent, 43 (1983): 53-62
  4.  Driscoll WS, et al., JASA. 1982; 105:1010-1013

1-800-228-5595
Manufactured for and Distributed in US by:
Zila Therapeutics, Inc.
P.O.Box 3889, Batesville, AR 72503
Rev. 1 1008