美国FDA再次扩大洗手液禁售清单

自新冠肺炎爆发以来，洗手液一直是美国抗击新冠肺炎的流行产品。免洗洗手液、免洗洗手凝胶、洗手喷雾等供不应求，我国也有很多企业在委托我们完成FDA注册后，成功出口大量产品。

然而据美国FDA调查发现，因意外摄入洗手液的儿童和喝洗手液替代酒精的年轻人也越来越多，这致使他们的甲醇中毒的风险增加。

在经过测试之后，美西时间7月11日，美国食品和药物管理局（FDA）扩大了禁用洗手液的清单，因为这些产品中可能含有甲醇等致命毒素，可以通过人体皮肤吸收或摄入。FDA建议消费者不要使用以下洗手液，因为它们都含有甲醇，或在同一工厂生产，FDA还表示，要避免使用这些公司的消毒剂。

4E Global's Blumen Clear Advanced Hand Sanitizer with 70% Alcohol

4E Global's Blumen Advanced Instant Hand Sanitizer Clear Ethyl Alcohol 70%

4E Global's BLUMEN Advanced Instant Hand Sanitizer Clear

4E Global's KLAR AND DANVER Instant Hand Sanitizer (labeled with Greenbrier International Inc.)

4E Global's MODESA Instant Hand Sanitizer Moisturizers and Vitamin E

4E Global's BLUMEN Advanced Hand Sanitizer

4E Global's BLUMEN Advanced Hand Sanitizer Aloe

4E Global's BLUMEN Advanced Instant Hand Sanitizer Lavender

4E Global's BLUMEN Clear LEAR Advanced Hand Sanitizer

4E Global's BLUEMEN Clear Advanced Hand Sanitizer

4E Global's The Honeykeeper Hand Sanitizer

4E Global's BLUMEN Advanced Hand Sanitizer Clear

4E Global's BLUMEN Clear Advanced Instant Hand Sanitizer

4E Global's BLUMEN Clear Advanced Instant Hand Sanitizer Aloe

4E Global's BLUMEN Clear Advanced Instant Hand Sanitizer Lavender

4E Global's BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol

4E Global's Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol

4E Global's Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol

4E Global's Blumen Antibacterial Fresh Citrus Hand Sanitizer

4E Global's Blumen Hand Sanitizer Fresh Citrus

4E Global's KLAR and DANVER INSTANT HAND SANTIZER

4E Global's Hello Kitty by Sanrio Hand Sanitizer

4E Global's Assured Instant Hand Sanitizer (Vitamin E and Aloe)

4E Global's Assured Instant Hand Sanitizer (Aloe and Moisturizers)

4E Global's Assured Instant Hand Sanitizer Vitamin E and Aloe

4E Global's Assured Instant Hand Sanitizer Aloe and Moisturizers

4E Global's BLUMEN Instant Hand Sanitizer Fragrance Free

4E Global's BLUMEN Instant Hand Sanitizer Aloe Vera

4E Global's Assured Aloe

AAA Cosmetica's bio aaa Advance Hand Sanitizer

AAA Cosmetica's LumiSkin Advance Hand Sanitizer 4 oz

AAA Cosmetica's LumiSkin Advance Hand Sanitizer 16 oz

AAA Cosmetica's QualitaMed Hand Sanitizer

DDI Multinacional's Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced

DDI Multinacional's Hand Sanitizer Agavespa Skincare

DDI Multinacional's Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare

Eskbiochem's All-Clean Hand Sanitizer

Eskbiochem's Esk Biochem Hand Sanitizer

Eskbiochem's Lavar 70 Gel Hand Sanitizer

Eskbiochem's The Good Gel Antibacterial Gel Hand Sanitizer

Eskbiochem's CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol

Eskbiochem's CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol

Eskbiochem's CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol

Eskbiochem's Saniderm Advanced Hand Sanitizer

Grupo Insoma's Hand sanitizer Gel Unscented 70% Alcohol

Limpo Quimicos' Andy’s Best

Limpo Quimicos' Andy’s

Limpo Quimicos' Gelclor

Limpo Quimicos' NeoNatural

Limpo Quimicos' Plus Advanced

Liqesa Exportacion or Liq-E-S.A.'s Optimus Lubricants Instant Hand Sanitizer

Maquiladora Miniara's Shine and Clean Hand Sanitizer

Maquiladora Miniara's Selecto Hand Sanitizer

Mystic International's Mystic Shield Protection hand sanitizer

Soluciones Cosmeticas’ Bersih Hand Sanitizer Gel Fragrance Free

Soluciones Cosmeticas’ Antiseptic Alcohol 70% Topical Solution hand sanitizer

Soluciones Cosmeticas’ Hand sanitizer (labeled with Wet Look Janitorial and Gardening Corp.)

Tropicosmeticos' Britz Hand Sanitizer Ethyl Alcohol 70%

Yara Elena De La Garza Perez Nieto's DAESI hand sanitizer

FDA洗手液注册须知

在美国，免洗消毒洗手液属于局部消毒的非处方药(OTC, Over-the-Counter)，与去屑洗发水、含氟牙膏、防晒霜等产品一样，受FDA监管。

 

已经上市的任何OTC产品必须符合一定条件，否则按NDA新药申请处理。含有这些有效成分的药品可以直接申请NDC，并按OTC上市销售，不用申请NDA。目前，美国FDA准许在OTC中使用的有效成分有数百种，美国FDA对OTC的管理和成分的认定全部公布在Federal Register上，有关条款多达数10卷，几十万页，研究美国OTC的管理方法是专业律师和顾问所从事的专业工作，申请OTC的NDC号码必须需要对号入座。

 

新安润咨询可以为出口企业提供防疫物资出口美国FDA服务