If you import or sell a fluoride toothpaste in Thailand, your current label is probably no longer complete. Two announcements under the Cosmetic Act, both published in the Royal Gazette on 24 December 2025 (B.E. 2568) and in force from the following day, add new label text and rewrite the warnings for every fluoride compound.
The two announcements
| Announcement | What it requires | Old labels |
|---|---|---|
| Cosmetic Committee: Labels of toothpaste containing fluoride, B.E. 2568 | The words “fluoride toothpaste” in Thai, and the total fluoride content in ppm | Leftover stock may be used for up to 2 years from the effective date |
| Cosmetic Committee: Label warnings for ingredients (No. 9), B.E. 2568 | New warnings for 20 fluoride compounds, separately for toothpaste, mouthwash and other oral products | Leftover stock may be used for up to 2 years from the effective date |
What the label must now show
- The product type: “ยาสีฟันผสมฟลูออไรด์” (fluoride toothpaste) or words with the same meaning, in Thai.
- Total fluoride in ppm: calculated as fluoride ion, for example “ปริมาณฟลูออไรด์ 1,000 พีพีเอ็ม” (fluoride 1,000 ppm).
- The warnings for the fluoride compound you use, in the exact Thai wording below.
- Everything else required by the 2019 cosmetic label announcement: name, ingredients, importer, batch, dates and notification number.
The exact Thai warning text
The warnings are prescribed word for word and must appear in Thai. Replace [compound] with the name of the fluoride compound in your formula, for example Sodium fluoride.
| Product | Warnings (Thai, as prescribed) |
|---|---|
| Toothpaste | 1. เด็กอายุต่ำกว่า 3 ปีควรใช้ยาสีฟันปริมาณขนาดแตะขนแปรงพอเปียก หรือเท่าเมล็ดข้าวสาร เด็กอายุ 3 - ต่ำกว่า 6 ปี ควรใช้ยาสีฟันปริมาณเท่าเมล็ดข้าวโพด หรือเมล็ดถั่วลันเตา และมีผู้ใหญ่ดูแลขณะแปรงฟัน 2. ในกรณีที่เด็กได้รับสารฟลูออไรด์จากแหล่งอื่นด้วย ให้ปรึกษาแพทย์ หรือทันตแพทย์ 3. มีสาร [compound] |
| Mouthwash | 1. ห้ามใช้ในเด็กอายุต่ำกว่า 6 ปี ในกรณีที่เด็กได้รับสารฟลูออไรด์จากแหล่งอื่นด้วย ให้ปรึกษาแพทย์ หรือทันตแพทย์ 2. มีสาร [compound] |
| Other oral products | มีสาร [compound] |
The new warnings apply to 20 compounds: Ammonium monofluorophosphate, Sodium monofluorophosphate, Potassium monofluorophosphate, Calcium monofluorophosphate, Calcium fluoride, Sodium fluoride, Potassium fluoride, Ammonium fluoride, Aluminium fluoride, Stannous fluoride, Cetylamine hydrofluoride, Olaflur, N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride, Octadecenyl-ammonium fluoride, Sodium fluorosilicate, Potassium fluorosilicate, Ammonium fluorosilicate, Magnesium fluorosilicate, Nicomethanol hydrofluoride, Magnesium fluoride.
How much fluoride is allowed, and how to state it
In toothpaste, total fluoride may not exceed 0.15% calculated as fluoride, which is 1,500 ppm. If you combine several fluoride compounds, the total of all of them counts. Your formula lists the compound, not the fluoride, so convert it before you print:
| Compound | Fluoride share | Example in formula | Fluoride on label |
|---|---|---|---|
| Sodium fluoride | 45.2% | 0.22% | about 1,000 ppm |
| Sodium monofluorophosphate | 13.2% | 0.76% | about 1,000 ppm |
| Stannous fluoride | 24.2% | 0.454% | about 1,100 ppm |
The calculation is: percent of compound × fluoride share × 10,000 = ppm fluoride. Ask your factory for the certificate of analysis and state the figure it supports.
Deadlines
- 25 December 2025: both announcements in force. New print runs should already use the new text.
- Up to 2 years from that date: leftover stock of labels printed before may still be used, but not beyond two years. After that, every unit on the market needs the new label.
- The grace period is for leftover labels, not for new printing. Reprinting the old design now only creates stock you will have to scrap.
Checklist before you print
- “ยาสีฟันผสมฟลูออไรด์” appears on the label.
- Total fluoride is stated in ppm and matches the certificate of analysis.
- It does not exceed 1,500 ppm in total.
- The three toothpaste warnings are printed word for word, with your compound name.
- Mouthwash in the same range carries its own warning set.
- Old label stock is counted, and the date it must be used up is in your plan.