SyDERMA - Skin protectant plus first aid antiseptic.
SyDERMA product profile

Product: SyDERMA® Skin Protectant plus First Aid Antiseptic with antimicrobial action.
Classification: SyDERMA® is formulated as a topical skin lotion to protect injured or exposed skin from harmful or annoying irritants and to help prevent bacterial contamination of treated skin. It complies with the Food and Drug Administration's monographs for skin protectants and first aid antiseptic drug products for over the counter human use. SyDERMA® has been assigned a National Drug Code number by the Food and Drug Administration.
Indications: When used properly, SyDERMA® will help prevent skin irritation and will temporarily provide protection for previously compromised skin. It addition, its first aid antiseptic properties help prevent skin infection and bacterial contamination
Usage: SyDERMA® is used to protect skin from abuse by irritating solutions and to prevent bacterial contamination in those environmental situations where extra protection of this nature is desirable. It does not block skin pores, therefore allowing the skin to breathe and perspire normally. It does not compromise the normal sensation of touch nor interfere with the natural dexterity of the skin. An application of approximately 1 cc is usually sufficient to treat an area the size of an average sized pair of hands. Upon application it should be allowed to dry thoroughly for a period of 1 to 3 minutes. Once dry it resists removal by repeated washing or scrubbing. The diminution of SyDERMA® on the skin surface occurs gradually over a period of several hours as the epithelium layer of skin is sloughed off. It should be applied as needed to replenish protection up to three times daily. SyDERMA® is effective as both a bacteria growth inhibitor and a skin protectant for up to 6 hours following application.
Precautions: SyDERMA® is classified as non-irritating to both skin and eyes and orally non-toxic in accordance with the Federal Hazardous Substances Act, 16 CFR, Section 1500. It is designed for external use only and should not be used in the eyes or on existing infections. SyDERMA® is not recommended as a substitute for customary protective practices, such as the wearing of gloves or the washing of hands.
Skin Protection Properties: SyDERMA® will provide effective protection for up to 6 hours from potential irritants such as concentrated Hydrochloric Acid causing harm to the skin. In vitro tests have shown that SyDERMA® protects against solutions such as water, blood, saliva, urine, hydrogen peroxide, alcohol and detergent for an extended period of time.
Microbiological: SyDERMA® provides an effective zone of inhibition on treated skin for up to 6 hours against the Properties growth of bacteria most commonly found on human skin. As a bactericide it kills 99.9% of common strands of bacteria within 30 seconds of contact.
Chemical: At 50 parts per million (PPM) concentration SyDERMA® has a Chlorine Equivalency of 200 PPM. Properties SyDERMA® has a Phenol Coefficient of 5.26. Its pH value is between 6.5 and 7.5.
Available Sizes and National Drug Codes:
2 oz net weight with disc top dispenser
8 oz net weight with 1 cc pump dispenser
16 oz net weight with 1 cc pump dispenser
32 oz net weight with 1 cc pump dispenser

NDC 62021-1000-04
NDC 62021-1000-03
NDC 62021-1000-02
NDC 62021-1000-01

Container Specifications: 2 oz containers are Low Density Polyethylene (LDPE); other containers are High Density Polyethylene (HDPE); disc tops are Polypropylene; pumps are HOPE and Polypropylene and utilize stainless steel for ball valves and spring. All materials comply with Code of Federal Regulations food standards.
Active Ingredients: Triclosan, 0.3%; Dimethicone, 3.0%

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NuTek International, Inc. • 704-1 West Park Ave. • Edgewater, FL 32132 • 386.426.7088 • fax 386.426.7021

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SyDERMA - Skin protectant plus first aid antiseptic.