This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Oculus Partner Misleads on Wound Cleaner

WASHINGTON, D.C. ( TheStreet) -- The U.S. Food and Drug Administration is demanding that a licensee of Oculus Innovative Sciences (OCLS) stop marketing a wound-cleansing product containing common diluted bleach as a pathogen-killing drug.

FDA sent a warning letter to Union Springs Pharmaceuticals on May 23 accusing the company of making misleading claims about MyClyns Personal Protection Spray. Union Springs peddles MyClyns to law enforcement agencies, fire departments and emergency medical responders for use as an antimicrobial agent after exposure to hepatitis C, HIV, MRSA and other dangerous pathogens.

But MyClyns only has FDA clearance as a simple medical device used to clean and moisten wounds. By claiming MyClyns can prevent infection from potentially dangerous pathogens, Union Springs is "misbranding" the product as a drug in violation of federal law, FDA says.

"We are not aware of sufficient evidence that shows MyClyns Personal Protection Spray is generally recognized as safe and effective as a topical antimicrobial that can prevent infection from Human Immunodeficiency Virus (HIV), Hepatitis C, or MRSA after exposure to blood or other bodily fluids," the FDA warning letter states.

Union Springs sells MyClyns under a license granted by Oculus Innovative Sciences, owner of the wound-cleansing product. Oculus sells the same product under other various brand names including Microcyn.

Oculus makes similar drug-like claims about Microcyn, including the following description found on the company's web site:

"Several solutions derived from this platform have demonstrated, in a variety of research and investigational studies, the ability to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria (including MRSA and VRE), viruses, fungi and spores; increase blood flow to the wound site; and reduce both inflammation and pain while assisting in faster wound closure."

Oculus spokesperson Dan McFadden defended the way Oculus markets Microcyn. "Internally, all our wound care and dermatology products marketed in the U.S. are fully compliant with FDA-cleared claims."

McFadden did not explain how the drug-like claims Oculus makes about Microcyn are different or compliant with FDA while those made by Union Springs about MyClyns are not.

McFadden added that Oculus is aware that "Union Springs is working with the FDA to resolve their issue. We are on standby to help our partners if they need assistance."

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,173.90 +41.93 0.24%
S&P 500 1,994.96 -4.02 -0.20%
NASDAQ 4,542.7770 -9.9820 -0.22%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs