About Bracco Diagnostics

Important:
RSDL has been cleared for marketing by the Food and Drug Administration as a medical device for the decontamination of skin exposed to chemical agents and certain biological toxins. The US Army was the sponsor of this application, and the approval is held by the Office of the Army Surgeon General. Although RSDL has been cleared for sale, it still requires follow-on testing prior to adoption for fielding in military operations. Additional military required tests are ongoing or planned. Results of this testing could have an impact on the safe use of this product.

Description:
RSDL is a topical decontamination solution that has been tested and shown to reduce toxic effects from exposure to chemical warfare agents (VX and HD) and T-2 toxin. RSDL contains Dekon 139 and a small amount of 2,3 butadiene monoxime (DAM). These compounds are dissolved in a solvent composed of polyethylene glycol monomethyl ether (MPEG) and water. This solvent system is particularly important as it promotes the decontamination reaction by actively desorbing, retaining and sequestering the chemical agent, while the active ingredient (Dekon 139) chemically reacts with, and rapidly neutralizes the vesicant chemical or the organophosphorous nerve agent. This reaction starts immediately and neutralization is usually complete within seconds or a few minutes.

Precautions & Warnings


General:
For external use only. Contact with eyes and mucous membranes should be avoided. RSDL should not be used for wound decontamination because its effects on wounds and effects resulting from its absorption through the wound have not been studied.

Absorption:
Avoid extended contact with the skin. In emergency conditions, does not require immediate removal from the skin and can be left on under protective clothing, but should be rinsed as soon as it is safe to do so. One of the ingredients (DAM) is absorbed through the skin. RSDL has not been tested in humans using amounts required for decontamination. Intravenous injections of DAM have been shown to cause serious systemic toxicity up to and including a transient comatose state (unconsciousness). There have been no instances of death. Topical adverse effects are not expected to be nearly as severe as with intravenous administration. Pending further studies, do not use RSDL for whole body decontamination or use excessive quantities.

Flammability:
The RSDL vehicle (MPEG) when combined with some commonly used decontamination materiels, i.e., solid powdered HTH (calcium hypochlorite) or solid powdered Super Tropical Bleach, causes spontaneous combustion. Should RSDL be used on the same decontamination line as either of these products, care must be taken to keep them apart. Do not discard RSDL packaging and sponge into containers that contain or have contained HTH (high test hypochlorite) or Super Tropical Bleach.

Pregnancy:
DAM has been shown to cross the placental barrier but teratogenicity studies have not been performed ; thus RSDL should only be used during pregnancy when absolutely necessary. RSDL has been shown to be non-mutagenic and inhalation and reproductive studies in rats have shown RSDL not to cause any ill effects.

Usage:
The full strength solution is applied on body surfaces after exposure to chemical warfare agents (RSDL should not be used before exposure since its effectiveness following prophylactic use has not been evaluated). Generally, one 21 mL packet is sufficient to decontaminate hands, neck, and face. The packaging and sponge should be discarded after single use.

How Supplied:
The FDA has cleared the use of RSDL in 21 and 42 mL packets. Each ml of solution contains 1.25 M or 173 mg of Dekon 139 and 35-43 mg of DAM in an MPEG and water solvent.*


  For Additional Information, Please Consult the Material Safety Data Sheet.

Notes:
* The 500 mL bottle is not approved for skin decontamination use in the United States.