This Day On The Street
Continue to site
ADVERTISEMENT
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

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 - Get Report) 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

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
OCLS $1.52 0.00%
AAPL $126.44 0.00%
FB $87.28 0.00%
GOOG $523.40 0.00%
TSLA $280.02 0.00%

Markets

DOW 17,730.11 -27.80 -0.16%
S&P 500 2,076.78 -0.64 -0.03%
NASDAQ 5,009.2140 -3.9090 -0.08%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs