| 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% |