PT INTEGRATED HEALTHCARE · 66-41 · INDONESIA
For PT INTEGRATED HEALTHCARE, import alert is 66-41; country is INDONESIA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Listerine Cool Mint Mouthwash; product code is 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C; date published is 03/16/2020; address is K-Link Tower Lt 12 Zona , Jln. Jendral Gatot Subroto 59A , Jakarta, Jabotabek INDONESIA, verified against its source on 2026-10-01.
- Firm
- PT INTEGRATED HEALTHCARE verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- INDONESIA verified
- Address
- K-Link Tower Lt 12 Zona , Jln. Jendral Gatot Subroto 59A , Jakarta, Jabotabek INDONESIA verified
- Date published
- 03/16/2020 verified
- Product code
- 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. verified
- Product
- Listerine Cool Mint Mouthwash verified
- FDA notes
- Labeling appears to contain statements which appear to make health claims that would render the product a "drug" within the meaning of the FD&C Act. It also appears to contain active ingredients commonly seen in over-the-counter drug products intended for oral healthcare, but the label fails to include a "Drug Facts" panel and lacks adequate directions for use. verified
What the source says
PT INTEGRATED HEALTHCARE Date Published : 03/16/2020 K-Link Tower Lt 12 Zona , Jln. Jendral Gatot Subroto 59A , Jakarta, Jabotabek INDONESIA
— accessdata.fda.gov, retrieved 2026-09-15
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
66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 03/16/2020 Desc: Listerine Cool Mint Mouthwash Notes: Labeling appears to contain statements which appear to make health claims that would render the product a "drug" within the meaning of the FD&C Act. It also appears to contain active ingredients commonly seen in over-the-counter drug products intended for oral healthcare, but the label fails to include a "Drug Facts" panel and lacks adequate directions for use.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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