Hyundai Pharm. Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)
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
- 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
- 55, Jandari-Gil, Pungse-Myeon , Dongnam-Gu , Cheonan-Si, Chungcheongnam-do KOREA (THE REPUBLIC OF) verified
- Date published
- 04/06/2015 verified
- 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. each item verified
- 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 each item verified
- 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'. each item verified
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'.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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