Objective To observe the allergic and irritant reactions of Xiaoyu Ointment on the skin and evaluate its safety for topical application.Methods(1)Thirty healthy guinea pigs were randomly divided into a blank base group,a positive drug(2,4-dinitrochlorobenzene)group,and low-,medium-,and high-dose Xiaoyu Ointment groups.On day 0,7,and 14,the left abdominal area of the guinea pigs was shaved and treated with the ointment for sensitization.On day 28,the right abdominal area was shaved and treated to induce an allergic reaction.Skin reactions were observed,and allergy scores and histopathological examinations were performed.(2)Thirty-six healthy New Zealand rabbits were randomly divided into intact skin low-,medium-,and high-dose Xiaoyu Ointment groups and damaged skin low-,medium-,and high-dose Xiaoyu Ointment groups.Xiaoyu Ointment and a blank base were applied to both sides of the spine of each rabbit for 15 consecutive days,respectively.Skin reactions were observed,and irritation intensity scores and histopathological examinations were performed.Results Xiaoyu Ointment showed weak sensitization on guinea pig skin and did not cause irritation on intact rabbit skin.However,mild irritation was observed on damaged skin.Conclusion Xiaoyu Ointment has weak skin sensitization and no significant irritation,making it suitable for further clinical application and promotion.