SyDERMA® Skin Protectant plus First Aid Antiseptic is the most comprehensive personal protection product of its kind available. It is the result of years of scientific research and testing and has been specially formulated to provide the wearer the most comprehensive protection available. SyDERMA® has been thoroughly tested by independent laboratories and has been proven effective and yet safe for the wearer.

SyDERMA® is specifically formulated to provide additional protection for the wearer in those environments and situations where increased protection against external environmental irritants or cross contamination or infection by harmful bacteria is desired. SyDERMA® contains ingredients that have been proven to be effective barriers to harmful, external environmental irritants. In addition, it contains antimicrobial agents chosen for their ability to both destroy bacteria most commonly found on the skin as well as provide an effective zone of inhibition to its growth. It is formulated in the structure of a skin lotion and is designed to be applied to the skin, in a "rub on" fashion. Drying time on clean, moisture free skin is approximately one to three minutes. The maximum effectiveness of SyDERMA® to protect the skin is best realized once the product is completely dried on the skin surface. Incomplete drying will reduce its overall effectiveness. Also, washing the skin before it is completely dry may remove the product from the skin and therefore reduce its effectiveness. Once SyDERMA® has completely dried on the skin surface, it is resistant to removal by washing, even repeated washing with soap.

Once dry, SyDERMA® becomes transparent and provides a coating or shield over the skin much like a membrane. It does not affect the dexterity or breatheability of the skin. SYDERMA® has been tested according to protocols established by the Food and Drug Administration and proven effective as a first aid antiseptic drug against bacteria such as Escherichia coli, Salmonella typhimurium, Staphylococcus aureus, Streptococcus pyogenes, Acinetobacter anitritus, Candida albicans, and Pseudomonas aeruginosa.

SyDERMA® is uniquely formulated and manufactured to maintain its durable barrier and bactericidal properties on the skin surface for a period of four to six hours despite repeated hand washing.

SyDERMA® has been tested and proven effective under laboratory conditions in protecting the human hand against repeated assault by concentrated Hydrochloric Acid (HCl) for a period of six hours. Additional in vitro testing has demonstrated its effectiveness as a barrier to water, blood, urine, saliva, alcohol, detergent, hydrogen peroxide, and hydrochloride acid.

SyDERMA® will remain effective up to six hours as long as the treated skin is intact. This is an especially important benefit in those situations where one must constantly wash their hands and other exposed skin surfaces. In many situations, after washing their hands, wearers come in contact with harmful substances and environmental irritating agents that could, without the presence of SyDERMA®, strip the skin of its own natural protection. Cross contamination is an important concern for personnel in these industries, especially in those environments where items such as instrumentation or food products are constantly being handled and processed. Cross contamination and cross infection can be greatly reduced in these situations where the antimicrobials present in SyDERMA® are available in a gentle but extremely effective and efficient medium.
SyDERMA® is classified as an over the counter drug and is in compliance with the requirements and regulations of applicable United States regulatory agencies. It has been registered with the Food and Drug Administration and they have assigned the following National Drug Code numbers to SyDERMA®:

2 oz bottle:	62021-1000-04	8 oz bottle:	62021-1000-03
16 oz bottle:	62021-1000-02	32 oz bottle:	62021-1000-01

SyDERMA® complies with the following two (2) monographs published by the United States Food and Drug Administration. Products of the nature of SyDERMA® must adhere to the specifications and criteria contained in these monographs in order to be marketed in the United States.

1. Skin Protectant Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; Proposed Rule.
   

   The appropriate monograph can be found in the Federal Register, Part II, Volume 48, Number 32 dated Tuesday, February 15, 1983, Proposed Rules published by the Department of Health and Human Services of the United States Food and Drug Administration. This information is contained in Part 347 starting on page 6832 and continuing for several pages thereafter.

2. Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for First Aid Antiseptic Drug Products; Proposed Rule.
   

   The appropriate monograph can be found in the Federal Register, Part IV, Volume 56, Number 140 dated Monday, July 22, 1991, Proposed Rules published by the Department of Health and Human Services of the United States Food and Drug Administration. This information is contained in Part 333 starting on page 33676 and continuing for several pages thereafter