Reference Source

Small Lab Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)

For Small Lab 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 ACNE SERUM | ACNE SERUM | ACNE SERUM | ACNE SERUM | ACNE SERUM; product code is 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - -- Skin Care Prep | 64 X - - 06 Salicylic Acid (Keratolytic) | 64 X - - -- Keratolytic | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 05/08/2025; address is 243-15 Tekeunojungang-Ro , Yuseong, Daejeon KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

Firm
Small Lab 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
243-15 Tekeunojungang-Ro , Yuseong, Daejeon KOREA (THE REPUBLIC OF) verified
Date published
05/08/2025 verified
Product code
53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - -- Skin Care Prep | 64 X - - 06 Salicylic Acid (Keratolytic) | 64 X - - -- Keratolytic | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
ACNE SERUM | ACNE SERUM | ACNE SERUM | ACNE SERUM | ACNE SERUM each item verified
FDA notes
This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Small Lab Co., Ltd. Date Published : 05/08/2025 243-15 Tekeunojungang-Ro , Yuseong, Daejeon KOREA (THE REPUBLIC OF) 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 05/08/2025 Desc: ACNE SERUM Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. 53 L - - -- Skin Care Prep Date Published: 06/24/2026 Desc: ACNE SERUM Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. 64 X - - 06 Salicylic Acid (Keratolytic) Date Published: 05/08/2025 Desc: ACNE SERUM Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. 64 X - - -- Keratolytic Date Published: 06/24/2026 Desc: ACNE SERUM Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/08/2025 Desc: ACNE SERUM Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”.

accessdata.fda.gov, retrieved 2026-09-15

Source

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