Hyundai Pharm. Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)
For Hyundai Pharm. 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 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 | BUMOOLY-S Solution; 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 2026-10-01.
- 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
- 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 | BUMOOLY-S Solution 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. 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'. | 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'. 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)
— accessdata.fda.gov, retrieved 2026-09-24
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
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 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 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: 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 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 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: 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'. 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'.
— all from accessdata.fda.gov, retrieved 2026-09-24
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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