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Specifically, letters were issued to companies manufacturing the following types of OTC products: hand sanitizer (16) unspecified OTC drug (7) sunscreen (5) nasal spray (3) oral use (toothpaste, mouthwash) (3) eye drops (1) topical pain relief (1) antidandruff shampoo (1) In addition to OTC manufacturers, 12 letters were issued to compounders and 11 letters were issued to clinical investigators or sponsors following inspections conducted as part of FDAs Bioresearch Monitoring Program (BIMO)

Studies show the compound crosses the blood-brain barrier efficiently despite its peptide structure, achieving central nervous system concentrations sufficient for biological activity following systemic administration