Korean: 3-(N-헥사데실-N-2-하이드록시에틸암모니오)프로필비스(2-하이드록시에틸)암모늄다이플루오라이드 ·
No specific rule on file.
Restricted Annex III/37
Maximum: 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Conditions: Product type: Oral products
Required label warning: Contains 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only")labelling is obligatory:Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor
Source: EU CosIng — Annex III · checked Oct 16, 2026
No specific rule on file. The FDA regulates few cosmetic ingredients by name; no rule does not mean approval.
How 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride is treated in 2 more markets, from the overseas cosmetic regulation database compiled by Korea's MFDS. Always confirm with the regulator of that country before selling there.
| Market | Status | Conditions |
|---|---|---|
| AS ASEAN (10 countries) | Restricted | MFDS summary (Korean): * 【Restrictions】 Field of application and/or use : Oral hygiene products * 제한 【사용 범위】 : 구강 위생 제품 * 【Restrictions】 Maximum authorised concentration in the finished cosmetic product : 0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F... |
| TW Taiwan | Restricted | MFDS summary (Korean): ※ 染髮、脫色、脫染及燙髮產品之應刊載之注意事項，應依衛生福利部公告刊載之。 ※ 染髮產品之限量標準：係指該成分依產品使用說明書混合後之最高允許使用量。 ※ 化粧品之外包裝或容器，應明顯標示本表所列成分之注意事項。因外包裝或容器表面積過小或其他特殊情形致不能標示者，應於標籤、仿單或以其他方式刊載之。 ※ 本表所稱之口腔製劑，包含非藥用牙膏、漱口水類及美白牙齒類等化粧品。 ※ 化粧品宣稱效能者，須符合化粧品標示宣傳廣告涉及虛偽誇大或醫療效能認定準則規定。 * 단서조항 : ※ 染髮、脫色、脫染及燙髮產品之應刊載之注意事項，應依衛生福利部公告刊載之。 ※... |
Source: MFDS cosmetic ingredient use restrictions — overseas regulations · checked Oct 16, 2026
3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride 3-(N-헥사데실-N-2-하이드록시에틸암모니오)프로필비스(2-하이드록시에틸)암모늄다이플루오라이드
Information only, not medical advice. Rules change — always check the linked official source. If you are pregnant, have a skin condition or allergies, ask a dermatologist or pharmacist.