AMMONIUM FLUORIDE

US FDA substance register · UNII 4QT928IM0A · registered name AMMONIUM FLUORIDE · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

Ammonium fluoride is a fluoride salt having ammonium (NH4+) as the counterion. It is a fluoride salt and an ammonium salt.

Source: PubChem

Restricted

Taiwan · United Kingdom

Source: ASEAN Cosmetic Directive · EU Cosmetics Regulation · MFDS (Korea) cosmetic regulatory information · Taiwan FDA cosmetic ingredients · Taiwan FDA cosmetic regulations · UK cosmetics regulations (OPSS)

Argentina · Brazil

• Field of application and/or use : (a) Toothpastes (b) Mouthwashes
• Maximum concentration permitted at final product : 0.15% expressed as fluorine. When it is mixed with other fluorine compounds permitted, the maximum concentration fluoride total must not exceed 0.15%
• Use conditions and warnings that must appear on the label : a.- - Contains ammonium fluoride. - For toothpastes containing between 0.1-0.15% fluoride unless it is already labeled as contra (eg , only for adults) must show in its labeling the following: "children of 6 years and younger: use an amount the size of a pea under adult supervision during brushing to minimize the risk of ingestion in case of intake of fluoride from other. sources consult a dentist or doctor. b.- Contains ammonium fluoride. -Keep out of the reach of children. No use in children under 6 years

ASEAN

• Field of application and/or use : Oral hygiene products
• 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 concentration must not exceed 0.15%.
• Other limitations and requirements : Thailand only 0.11% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.11%.
• Conditions of use and warning which must be printed on the labels : • Contains ammonium fluoride • Children of 6 years and under: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor(12)

European Union

• Product Type, body parts : Oral products
• Maximum concentration in ready for use preparation : 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
• Wording of conditions of use and warnings : Contains ammonium fluoride. 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”) the following 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.”

Korea’s toxic-substance GHS classification: Danger · H315 (category 2) · H331 (category 3) · H301 (category 3) · +1 more

Source: Korea toxic substances GHS register (NIER)

EU Cosmetics Regulation, Annex III (restricted substances), entry 33 · maximum concentration 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % · applies to Oral products

Source: EU restricted substances (Annex III)

Restriction III/33

Source: EU CosIng ingredient list