Pharmcle Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)
For Pharmcle Co., Ltd., import alert is 66-41; country is KOREA (THE REPUBLIC OF); import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is ZAPS Sanitizer Spray | ZAPS Sanitizer Spray; product code is 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 95 R - - GI Hand Washing Sanitizer, Ultraviolet Hygiene Products, Non-Medical; date published is 08/24/2020; address is 106 Sandanro67beon-Gil; Danwon , Ansan, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-10-01.
- Firm
- Pharmcle Co., Ltd. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- 106 Sandanro67beon-Gil; Danwon , Ansan, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 08/24/2020 verified
- Product code
- 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 95 R - - GI Hand Washing Sanitizer, Ultraviolet Hygiene Products, Non-Medical each item verified
- Product
- ZAPS Sanitizer Spray | ZAPS Sanitizer Spray each item verified
- FDA notes
- The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Disinfection of hands and skin', and '99.9% Sterilization of bacteria and viruses'. In addition, the product's principal display panel contains a depiction of the novel coronavirus with a slash in the middle, which suggests that the product is effective in preventing infection or disease specifically from the novel coronavirus. | The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Disinfection of hands and skin', and '99.9% Sterilization of bacteria and viruses'. In addition, the product's principal display panel contains a depiction of the novel coronavirus with a slash in the middle, which suggests that the product is effective in preventing infection or disease specifically from the novel coronavirus. each item verified
What the source says
Pharmcle Co., Ltd. Date Published : 08/24/2020 106 Sandanro67beon-Gil; Danwon , Ansan, Gyeonggi KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 08/24/2020 Desc: ZAPS Sanitizer Spray Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Disinfection of hands and skin', and '99.9% Sterilization of bacteria and viruses'. In addition, the product's principal display panel contains a depiction of the novel coronavirus with a slash in the middle, which suggests that the product is effective in preventing infection or disease specifically from the novel coronavirus. 95 R - - GI Hand Washing Sanitizer, Ultraviolet Hygiene Products, Non-Medical Date Published: 08/24/2020 Desc: ZAPS Sanitizer Spray Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Disinfection of hands and skin', and '99.9% Sterilization of bacteria and viruses'. In addition, the product's principal display panel contains a depiction of the novel coronavirus with a slash in the middle, which suggests that the product is effective in preventing infection or disease specifically from the novel coronavirus.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html