Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_2858
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 2858
Character Range: 1309558–1311192

2858                                      KALMIA LATIFOLIA                                                                              A, H      Beta-arbutin is a mandatory component of Kalmia latifolia.
                                                                                                                                                  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%.