Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_670
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 670
Character Range: 311121–312685

670                                       ARCTOSTAPHYLOS UVA-URSI                                                           A, E, H   Beta-arbutin is a mandatory component of Arctostaphylos uva-ursi.

                                                                                                                                      When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.

                                                                                                                                      When for dermal application exclusively to the face:

                                                                                                                                      a) the concentration of beta-arbutin in the medicine must not be more than 7%;

                                                                                                                                      b) hydroquinone is a mandatory component; and

                                                                                                                                      c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.

                                                                                                                                      When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.