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The agency says it has only limited safety information for the proposed methods of administration and cannot determine whether the compound would harm humans

The reasoning is chemical: copper can affect the stability of some ingredients when they sit on the skin at the same time

ACS Appl Mater Interfaces 10:97929801

Pre-blended Reconstitution Reference (verify against supplier COA) Total mg per vial 20 mg (4 full doses) BAC water added 2.0 mL Concentration (combined) 10 mg/mL Approx weekly draw at 4.8 mg total 0.48 mL = 48 units U-100 Total mg per vial 20 mg (4 full doses) BAC water added 3.0 mL Concentration (combined) 6.67 mg/mL Approx weekly draw at 4.8 mg total 0.72 mL = 72 units U-100 Total mg per vial 20 mg (4 full doses) BAC water added 2.5 mL Concentration (combined) 8 mg/mL Approx weekly draw at 4.8 mg total 0.60 mL = 60 units U-100 These rows are illustrative only