Acute and subacute toxicities of azulene gel compound drug (alveolus gel), containing cetylpyridinium chloride, azulene, mint oil, and allantoinchlorhydroxyalminium, were investigated to obtain the following results: The LD
50 value in the acute toxicity study was 250 times higher than the highest dose formulation of the compound drug, suggesting that the azulene gel compound drug might be used safely. In the subacute toxicity study, body weight, serum biochemistry (S-GOT, S-GPT, glucose, total protein, and blood urine nitrogen), and histopathological findings of the mandibule, esophagus, stomach, duodenum, liver, kidney, and spleen, did not show any significant difference compared to those of the intact control. Thus, the azulene gel compound drug may be applied safely as an external preparations in the oral cavity.
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