CAPSIN Topical Analgesic Lotion Package Insert

ACTIVE INGREDIENT: Capsaicin 0.025% (Regular Strength) NDC# 59263 025 02
Capsaicin 0.075% (Triple Strength) NDC# 59263 075 02

USES: For the relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, and sprains.

Warnings: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES AND MUCOUS MEMBRANES. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a poison control center (1-800-222-1222) immediately. Do not apply to irritated skin, to open wounds, or damaged skin. Do not bandage tightly or use with a heating pad. If condition persists for more than seven days, or worsens, or if symptoms clear up, and occur again within a few days, discontinue use and consult a physician. A temporary burning sensation may occur following the initial use of CAPSIN but generally diminishes or subsides when used as directed.

DIRECTIONS:

ADULTS: Apply a small amount of CAPSIN lotion directly to affected area(s) not more than three or four times daily. For optimum relief, continue to apply every day. CAPSIN is capped with a handy applicator to minimize waste; increase safety; and facilitate direct application to painful areas. Wash hands with soap and water after each use.

Children under 18 years of age: Consult a physician.

Close cap tightly after use.

HOW DOES CAPSIN WORK?
Oleoresin of Capsicum contains a variety of natural substances called Capsaicinoids. The most widely investigated of these is Capsaicin. Capsaicin has been shown to inhibit pain sensation by depleting nerve fibers of the neurotransmitter Substance P. The propagation of many nerve impulses responsible for the perception of pain by the brain is initiated by the release of Substance P in the peripheral nervous system.

The exact mechanism of action is unknown. However, the action of Capsaicin derived from the Oleoresin of Capsicum is well documented in the relief of pain. When CAPSIN is used on a daily basis, and as directed, its effectiveness generally will continue to increase. The warming / burning sensation that may be experienced after its initial use is due to the stimulation of nerve tissues and the inhibition of the nervous system's ability to transmit pain signals to the brain.

As with most medicine, time of relief may vary from user to user. While some patients experience relief soon after the initial application of CAPSIN, others may take longer, possibly up to two months.

INACTIVE INGREDIENTS: Benzyl Alcohol, Propylene Glycol, Denatured Alcohol, Dimethylisosorbide, D-Limonene.

Distributed by PRYDE Pharmaceutical Corporation, Delray Beach, FL USA
Questions? Call us toll free: 1-866-PRYDE10.