2013 Re: T.R.U.E Test and gold Dear Health Care Professional ...

11.1 Allergens on Panel 1.2Nickel Sulfate (Position 1):Nickel sulfate hexahydrate (purity ≥98.5%) is used to formulate this patch. The active allergenic component is nickel. The gel vehicle is hydroxypropyl cellulose.The product is formulated to contain 200 mcg/cm 2 of nickel sulfate hexahydrate, which corresponds to 36 mcg of nickel per patch. Nickel is one of themost common metals in the environment and is found in most metal and metal-plated objects.Wool Alcohols (Lanolin) (Position 2):Wool alcohols, USP are a natural product obtained from the fleece of sheep. This allergen is a highly complex mixture of alcohols containing cholesterol,lanosterol, agnosterol, and their dihydro derivatives as well as straight and branched chain aliphatic alcohols. The active allergenic component has not beenidentified. The gel vehicle is povidone. The product is formulated to contain 1000 mcg/cm 2 of wool alcohols, which corresponds to 810 mcg of wool alcoholsper patch. Wool alcohols are a common constituent of many ointments, creams, lotions, and soaps.Neomycin Sulfate (Position 3):Neomycin sulfate, USP an antibiotic drug substance, is used to formulate this patch. The gel vehicle is methylcellulose. The product is formulated to contain230 mcg/cm 2 of neomycin sulfate, which corresponds to 186 mcg of neomycin sulfate per patch. Neomycin is a common antibiotic found in topical antibioticcreams, lotions, ointments, eye drops, and ear drops.26