|
|
Article: Hand soap maker's cleaning, ingredient tests gets warning.(Brief Article)
- Article from:
- Validation Times
- Article date:
- May 1, 2001
CopyrightCOPYRIGHT 2001 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
ORCHEM, a Fairfield, OH, maker of E-2 sanitizing hand soap, received a warning letter that charged the labels for the firm's product, which indicated use to reduce/eliminate microorganisms on the skin and prevent diseases, caused the product to be a drug for which ORCHEM lacked an NDA.
The product's active ingredient, benzalko-nium chloride (BTC 2125M), is considered a drug, the April 2 letter said, and the product was not considered for the OTC drug review because "we are not aware of a product so formulated and labeled having ever been commercially marketed before the review began."
Adding insult to injury, the soap also was deemed misbranded because ...