Zhuji Jianhe Paper Co., Ltd · 66-41 · CHINA
For Zhuji Jianhe Paper Co., Ltd · 66-41 · CHINA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CHINA; product is JIANHE 75% Alcohol Wipes | 75% ALCOHOL WIPES | JIANHE 75% Alcohol Wipes | JIANHE 75% Alcohol Wipes | JIANHE 75% Alcohol Wipes | 75% ALCOHOL WIPES | JIANHE 75% Alcohol Wipes | JIANHE 75% Alcohol Wipes | JIANHE 75% Alcohol Wipes | 75% ALCOHOL WIPES; product code is 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 61 H - - 99 Anti-Bacterial, N.E.C. | 62 F - - 23 Isopropyl Alcohol (Anti-Infective, Topical) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 99 Anti-Microbial N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C; date published is 08/11/2020; address is Anhua F/4 , No. 32 Huaxi Road; Xiaojiangzhen Xinchangxian , Shaoxing, Zhejiang CHINA, verified against its source on 2026-09-16.
- Firm
- Zhuji Jianhe Paper Co., Ltd verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- CHINA verified
- Address
- Anhua F/4 , No. 32 Huaxi Road; Xiaojiangzhen Xinchangxian , Shaoxing, Zhejiang CHINA verified
- Date published
- 08/11/2020 verified
- Product code
- 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 61 H - - 99 Anti-Bacterial, N.E.C. | 62 F - - 23 Isopropyl Alcohol (Anti-Infective, Topical) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 99 Anti-Microbial N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. each item verified
- Product
- JIANHE 75% Alcohol Wipes | 75% ALCOHOL WIPES | JIANHE 75% Alcohol Wipes | JIANHE 75% Alcohol Wipes | JIANHE 75% Alcohol Wipes | 75% ALCOHOL WIPES | JIANHE 75% Alcohol Wipes | JIANHE 75% Alcohol Wipes | JIANHE 75% Alcohol Wipes | 75% ALCOHOL WIPES each item verified
- FDA notes
- The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. | The product appears to be an unapproved new drug as the product's label suggests both that the product is a consumer antiseptic wash and consumer antiseptic rub. Thus, as formulated and labeled, the product does not conform to the Tentative Final Monograph or FDA's Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. | The product appears to be an unapproved new drug as the product's label suggests both that the product is a consumer antiseptic wash and consumer antiseptic rub. Thus, as formulated and labeled, the product does not conform to the Tentative Final Monograph or FDA's Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. | The product appears to be an unapproved new drug as the product's label suggests both that the product is a consumer antiseptic wash and consumer antiseptic rub. Thus, as formulated and labeled, the product does not conform to the Tentative Final Monograph or FDA's Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. each item verified
What the source says
Zhuji Jianhe Paper Co., Ltd Date Published : 08/11/2020 Anhua F/4 , No. 32 Huaxi Road; Xiaojiangzhen Xinchangxian , Shaoxing, Zhejiang CHINA 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 12/03/2020 Desc: JIANHE 75% Alcohol Wipes Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 03/04/2021 Desc: 75% ALCOHOL WIPES Notes: The product appears to be an unapproved new drug as the product's label suggests both that the product is a consumer antiseptic wash and consumer antiseptic rub. Thus, as formulated and labeled, the product does not conform to the Tentative Final Monograph or FDA's Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 12/03/2020 Desc: JIANHE 75% Alcohol Wipes Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. 61 H - - 99 Anti-Bacterial, N.E.C. Date Published: 12/03/2020 Desc: JIANHE 75% Alcohol Wipes Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. 62 F - - 23 Isopropyl Alcohol (Anti-Infective, Topical) Date Published: 12/03/2020 Desc: JIANHE 75% Alcohol Wipes Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 03/04/2021 Desc: 75% ALCOHOL WIPES Notes: The product appears to be an unapproved new drug as the product's label suggests both that the product is a consumer antiseptic wash and consumer antiseptic rub. Thus, as formulated and labeled, the product does not conform to the Tentative Final Monograph or FDA's Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 12/03/2020 Desc: JIANHE 75% Alcohol Wipes Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. 62 H - - 99 Anti-Microbial N.E.C. Date Published: 12/03/2020 Desc: JIANHE 75% Alcohol Wipes Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. 64 A - - 99 Disinfectant N.E.C. Date Published: 12/03/2020 Desc: JIANHE 75% Alcohol Wipes Notes: The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): '75% alcohol is specially prepared to inhibit bacteria safely and effectively . . . Effective inhibition of bacterial growth . . . achieve the effect of inhibiting bacteria'. Anti-septic hand rub products that do not contain one or more of the aforementioned statements are currently not subject to DWPE under this listing. 64 A - - 99 Disinfectant N.E.C. Date Published: 03/04/2021 Desc: 75% ALCOHOL WIPES Notes: The product appears to be an unapproved new drug as the product's label suggests both that the product is a consumer antiseptic wash and consumer antiseptic rub. Thus, as formulated and labeled, the product does not conform to the Tentative Final Monograph or FDA's Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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