PT INTEGRATED HEALTHCARE · 66-41 · INDONESIA
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
- 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 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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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