# Hyundai Pharm. Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Hyundai Pharm. Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is KOREA (THE REPUBLIC OF); product is BUMOOLY-S Solution | MOOLPAS-F Humectant with Tocopherol | BUMOOLY-S Solution | BUMOOLY-S Solution | BUMOOLY-S Solution | MOOLPAS-F Humectant with Tocopherol | BUMOOLY-S Solution | BUMOOLY-S Solution | BUMOOLY-S Solution | BUMOOLY-S Solution | MOOLPAS-F Humectant with Tocopherol; product code is 60 L - - 99 Analgesic, N.E.C. | 60 L - - 99 Analgesic, N.E.C. | 60 Q - - 35 Dibucaine HCl (Anesthetic) | 61 X - - 18 Diphenhydramine HCl (Anti-Histaminic) | 62 G - - 99 Anti-Inflammatory N.E.C. | 62 G - - 99 Anti-Inflammatory N.E.C. | 62 M - - 01 Camphor (Anti-Pruritic) | 62 M - - 08 Menthol (Anti-Pruritic) | 62 M - - 99 Anti-Pruritic N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 04/06/2015; address is 55, Jandari-Gil, Pungse-Myeon , Dongnam-Gu , Cheonan-Si, Chungcheongnam-do KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Hyundai Pharm. Co., Ltd. _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 55, Jandari-Gil, Pungse-Myeon , Dongnam-Gu , Cheonan-Si, Chungcheongnam-do KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 04/06/2015 _(verified: appears in the quote below)_
- **Product code:** 60 L - - 99 Analgesic, N.E.C. | 60 L - - 99 Analgesic, N.E.C. | 60 Q - - 35 Dibucaine HCl (Anesthetic) | 61 X - - 18 Diphenhydramine HCl (Anti-Histaminic) | 62 G - - 99 Anti-Inflammatory N.E.C. | 62 G - - 99 Anti-Inflammatory N.E.C. | 62 M - - 01 Camphor (Anti-Pruritic) | 62 M - - 08 Menthol (Anti-Pruritic) | 62 M - - 99 Anti-Pruritic N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** BUMOOLY-S Solution | MOOLPAS-F Humectant with Tocopherol | BUMOOLY-S Solution | BUMOOLY-S Solution | BUMOOLY-S Solution | MOOLPAS-F Humectant with Tocopherol | BUMOOLY-S Solution | BUMOOLY-S Solution | BUMOOLY-S Solution | BUMOOLY-S Solution | MOOLPAS-F Humectant with Tocopherol _(verified: each item appears in the quote below)_
- **FDA notes:** The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives?; ?Itching from insect bites'. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the product?s intended use from the product labeling includes but is not limited to the following;' 1) Antiinflammatory [sic] analgesic of the following symptoms; Sprain; contusion; myosalgia; backache; shoulder discomfort; neuralgia; rheumarthritis ... 2) Pernio'. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the product?s intended use from the product labeling includes but is not limited to the following;' 1) Antiinflammatory [sic] analgesic of the following symptoms; Sprain; contusion; myosalgia; backache; shoulder discomfort; neuralgia; rheumarthritis ... 2) Pernio'. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the product?s intended use from the product labeling includes but is not limited to the following;' 1) Antiinflammatory [sic] analgesic of the following symptoms; Sprain; contusion; myosalgia; backache; shoulder discomfort; neuralgia; rheumarthritis ... 2) Pernio'. _(verified: each item appears in the quote below)_

## What the source says

> Hyundai Pharm. Co., Ltd. Date Published : 04/06/2015 55, Jandari-Gil, Pungse-Myeon , Dongnam-Gu , Cheonan-Si, Chungcheongnam-do KOREA (THE REPUBLIC OF) 60 L - - 99 Analgesic, N.E.C. Date Published: 04/06/2015 Desc: BUMOOLY-S Solution Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives?; ?Itching from insect bites'. 60 L - - 99 Analgesic, N.E.C. Date Published: 04/06/2015 Desc: MOOLPAS-F Humectant with Tocopherol Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the product?s intended use from the product labeling includes but is not limited to the following;' 1) Antiinflammatory [sic] analgesic of the following symptoms; Sprain; contusion; myosalgia; backache; shoulder discomfort; neuralgia; rheumarthritis ... 2) Pernio'. 60 Q - - 35 Dibucaine HCl (Anesthetic) Date Published: 04/06/2015 Desc: BUMOOLY-S Solution Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. 61 X - - 18 Diphenhydramine HCl (Anti-Histaminic) Date Published: 04/06/2015 Desc: BUMOOLY-S Solution Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. 62 G - - 99 Anti-Inflammatory N.E.C. Date Published: 04/06/2015 Desc: BUMOOLY-S Solution Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. 62 G - - 99 Anti-Inflammatory N.E.C. Date Published: 04/06/2015 Desc: MOOLPAS-F Humectant with Tocopherol Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the product?s intended use from the product labeling includes but is not limited to the following;' 1) Antiinflammatory [sic] analgesic of the following symptoms; Sprain; contusion; myosalgia; backache; shoulder discomfort; neuralgia; rheumarthritis ... 2) Pernio'. 62 M - - 01 Camphor (Anti-Pruritic) Date Published: 04/06/2015 Desc: BUMOOLY-S Solution Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. 62 M - - 08 Menthol (Anti-Pruritic) Date Published: 04/06/2015 Desc: BUMOOLY-S Solution Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. 62 M - - 99 Anti-Pruritic N.E.C. Date Published: 04/06/2015 Desc: BUMOOLY-S Solution Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/06/2015 Desc: BUMOOLY-S Solution Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product?s intended use from the product labeling include but are not limited to the following; 'Aczema [sic]; dermatitis; erosion; miliaria; rhus dermatitis; pruritus; pernio; insect bite; hives'; 'Itching from insect bites'. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/06/2015 Desc: MOOLPAS-F Humectant with Tocopherol Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. An example of the product?s intended use from the product labeling includes but is not limited to the following;' 1) Antiinflammatory [sic] analgesic of the following symptoms; Sprain; contusion; myosalgia; backache; shoulder discomfort; neuralgia; rheumarthritis ... 2) Pernio'.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).