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ST. GEORGE – The US Food and Drug Administration released Thursday a final rule to ensure that hand sanitizers available over the counter are safe and effective for those who depend on it.
An FDA press release said the rule states that some over-the-counter hand sanitizers are not allowed in some hand sanitizers – formerly known as topical consumer antiseptics for use without water – marketed under the FDA OTC Drug Review. .
"Our focus today is to help consumers be confident that the over-the-counter hand sanitizers they use are safe and effective if they do not have access to water to clean themselves. wash with soap, "said Dr. Janet Woodcock, director of the FDA's Center for Evaluation and Drug Research, said in the press release.
Woodcock said the rule would apply to 28 active ingredients, including triclosan and benzethonium chloride, but that they needed "more data" on three other active ingredients, including l & # 39; 39; ethyl alcohol – the most used ingredient in hand sanitizers – to help the agency ensure that these products are safe and effective for regular use by consumers .
Antiseptic hand sanitizers for consumers are a practical alternative when handwashing with soap and water is not available. Millions of Americans use antiseptic friction daily, sometimes several times a day, to reduce bacteria on their hands.
Centers for Disease Control and Prevention advise washing your hands with soap and water is one of the most important steps consumers can take. avoid getting sick and prevent the spread of infections to others.
If you do not have water or soap, the CDC recommends using an alcohol-based hand sanitizer containing at least 60% alcohol.
In addition to ethyl alcohol, benzalkonium chloride and isopropyl alcohol are excluded from the other active ingredients to allow further study and submission of additional data on safety and health. 39; efficiency. At the moment, the FDA does not intend to take action to eliminate hand sanitizers containing these three active ingredients of the market.
According to an article published by the National Center for Information on Biotechnology, although it is clearly established that ethyl alcohol has carcinogenic properties when it is ingested as alcoholic beverages, Until now, there is nothing to associate the topical use of ethanol at risk of skin cancer.
However, the author went on to say that many studies on topical applications may be biased in the industry and that further independent studies should be conducted.
The FDA press release stated that less than 3% of the market would be affected by the publication of this final rule, as most antiseptics for over-the-counter users use ethyl alcohol as the active ingredient.
The complete list of active ingredients prohibited by the new rule includes the following:
- Benzethonium chloride
- Chlorhexidine gluconate2
- Iodized complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
- Iodine complex (alkylaryloxy polyethylene glycol phosphate ester)
- Methylbenzethonium chloride
- Nonylphenoxypoly (ethyleneoxy) ethanoliodine
- Phenol (equal to or less than 1.5% or greater than 1.5%)
- Iodinated poloxamer complex
- Povidone-iodine 5 to 10%
- Secondary amyltricresols
- Sodium oxychlorosene
- Triple dyeing
- Iodine Undecoylium Chloride Complex
In addition, as previously described in the proposed Consumer Antiseptic Rub 2016 regulation, the FDA has received several submissions in response to the 1994 TFM requesting the inclusion of the compounds identified below in the monograph:
- Polyhexamethylene biguanide
- Cetyl benzalkonium phosphate
- Cetylpyridinium chloride
- Salicylic acid
- Sodium hypochlorite
- Tea tree oil
- Combination of vegetable oil solution of potassium, sequestering agent of phosphate and triethanolamine
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