Reference Source

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

For Small Lab 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 ACNE SERUM | ACNE SERUM | ACNE SERUM | ACNE SERUM | ACNE SERUM; product code is 53 L - - -- Skin Care Prep | 53 L - - 06 Moisturizing (Skin Care Preparations) | 64 X - - -- Keratolytic | 64 X - - 06 Salicylic Acid (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 2026-10-01.

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 - - -- Skin Care Prep | 53 L - - 06 Moisturizing (Skin Care Preparations) | 64 X - - -- Keratolytic | 64 X - - 06 Salicylic Acid (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)

— 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

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”. 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”. 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”. 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”. 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”.

— all from accessdata.fda.gov, retrieved 2026-09-24

Source

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