Clinical Skin Assessment of BabyOrgano Cold Relief Roll - On: Efficacy in Cough and Cold Relief

BabyOrgano Natural Cold Relief Roll - On effective in Cough and Cold was clinically assessed for skin irritation potential on healthy human subjects by Single application patch test method (Primary Irritation Patch Test). This open - label, controlled, single - center was conducted on a group of healthy adult volunteers as per BIS 4011: 2018 guidelines with photo type III to V. A standardized patch test method was employed, wherein the BabyOrgano Natural Cold Relief Roll - On was applied to a small area of the subjects' skin. Observations were made at specific time intervals post - application, including 24, 48, and 72 hours, to assess any signs of erythema, edema, or other skin reactions. An additional follow - up period of 8 days was included, with visits scheduled at three days post - application and at T8 (one week after the initial patch removal) to monitor any delayed reactions. Screening and observations were conducted at T0 (before patch application), T1 (immediately after patch removal), T2 (24 hours after patch removal), and T8 (one week after patch removal). The primary endpoint was the change in erythema and edema scores, assessed by measuring the total irritation score 24 hours after patch removal. Three patches were used: Patch 1 with BabyOrgano Cold Relief Roll - On, Patch 2 as a negative control (0.9% saline), and Patch 3 as a positive control (1% sodium lauryl sulfate). Results showed Patch 1 and 2 were non - irritant, while Patch 3 caused irritation. All subjects completed the study without any dropouts. These findings confirm that BabyOrgano Natural Cold Relief Roll - On is non - irritant with 24 - hour Primary Irritation Patch Test for use on healthy human skin.