Skin Exposure Paste
"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Skin Exposure Paste
(Generic versions may still be available.)
Tests conducted in humans demonstrated that topical application of SERPACWA is not associated with acute skin irritation or with allergic sensitization. Exposure of SERPACWA-treated skin to ultraviolet light was not associated with skin irritation or allergic sensitization. SERPACWA application to 20% of body surface area did not impair normal heat exchange for personnel who were exposed to an environment that simulated the effects of wearing MOPP 4 gear. In the clinical trials in which a single dose of SERPACWA was applied to humans and left in place for a five hour period, no adverse events were found to be associated with SERPACWA use.
Read the Skin Exposure Paste (perfluoroalkylpolyether (pfpe), polytetrafluoroethylene (ptfe)) Side Effects Center for a complete guide to possible side effects
There have been no studies of the interaction of SERPACWA with any other drugs, and no drug-specific interactions were noted during any clinical trials. DEET products have been demonstrated to reduce the effect of SERPACWA. SERPACWA has been shown to have no effect on the M40 Chemical Protective Mask seal, but the compatibility between MOPP gear materials or battle dress uniform and SERPACWA has not been characterized.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The genotoxicity and carcinogenicity potential of SERPACWA was not evaluated. However, PFPE was negative in the standard Ames Assay at concentrations up to 5000 µg/plate. Nonclinical information was not submitted to assess the potential effect of SERPACWA on fertility.
Pregnancy Category C: Animal developmental toxicology studies have not been conducted with SERPACWA.
It is also not known whether SERPACWA can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. SERPACWA should be given to a pregnant woman only if clearly needed.
Because the effects of SERPACWA ingestion have not been studied in humans, caution should be exercised when SERPACWA is applied by a nursing woman.
The safety and effectiveness of this product have not been established in pediatric patients.
The safety and effectiveness of this product have not been established in patients 65 years and older.
Last reviewed on RxList: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Skin Exposure Paste Information
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