# PT INTEGRATED HEALTHCARE · 66-41 · INDONESIA — FDA import alert red lists: firms subject to detention without physical examination

For PT INTEGRATED HEALTHCARE · 66-41 · INDONESIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is INDONESIA; 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 2026-09-16.

- **Firm:** PT INTEGRATED HEALTHCARE _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** INDONESIA _(verified: appears in the quote below)_
- **Address:** K-Link Tower Lt 12 Zona , Jln. Jendral Gatot Subroto 59A , Jakarta, Jabotabek INDONESIA _(verified: appears in the quote below)_
- **Date published:** 03/16/2020 _(verified: appears in the quote below)_
- **Product code:** 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. _(verified: appears in the quote below)_
- **Product:** Listerine Cool Mint Mouthwash _(verified: appears in the quote below)_
- **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: appears in the quote below)_

## 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 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.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).