According to the rule (which amends one published in 1994), such ingredients are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded as OTC products. "Manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections," said FDA in apress statement.
Moreover, FDA said some ingredients may cause bacterial resistance or hormonal effects.
The following ingredients are not considered GRAS/GRAE for use as a consumer antiseptic wash:
- Cloflucarban
- Fluorosalan
- Hexachlorophene
- Hexylresorcinol
- Iodophors (Iodine-containing ingredients)
○ Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
○ Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
○ Nonylphenoxypoly (ethyleneoxy) ethanoliodine
○ Poloxamer—iodine complex
○ Povidone-iodine 5 to 10 percent
○ Undecoylium chloride iodine complex
- Methylbenzethonium chloride
- Phenol (greater than 1.5 percent)
- Phenol (less than 1.5 percent)
- Secondary amyltricresols
- Sodium oxychlorosene
- Tribromsalan
- Triclocarban
- Triclosan
- Triple dye
