T h e r a p e u t i c I n d e x 15 Adverse Effects No adverse effects have been reported. Contraindications No known contraindications. Special Precautions • Should not be used by patients having hypersensitivity to any of the ingredients • Children under 12 years of age should use under adult supervision • To be used only for external application Presentation PET bottle of 100 mL. Pharmacological Actions of Ingredients 1. Moisturizing action: Polysaccharides in Aloe vera act as humectants by facilitating transfer of moisture to the skin, and thus improve the hydration of the stratum corneum layer of the skin. Medium and long-chain fatty acids (e.g., palmitic acid, stearic acid, linoleic acid, oleic acid, and lauric acid) in Garcinia indica butter and Cocos nucifera oil help exert an emollient effect by filling up the spaces between skin flakes, reduce transepidermal water loss (TEWL), and enhance epidermal barrier function, thus helping to maintain skin hydration and integrity. 2. Skin barrier restoration: The skin barrier function is determined by the integrity of the main constituents of stratum corneum—the corneocytes and intercellular lamellar lipid bilayers. The lipids that constitute the stratum corneum are ceramides, cholesterol, and free fatty acids, which are responsible for the water permeability and the exchange of substances with the external environment. The unique, naturally occurring ceramides in Oryza sativa bran help replenish the skin lipids, significantly increase water content in the stratum corneum, significantly reduce transepidermal water loss (TEWL), and restore effective skin barrier function. Oryza sativa ceramides induce the hyaluronan synthase gene expression and prevent the degradation of hyaluronic acid, a key molecule having a unique capacity to bind and retain molecules in the skin and improve skin hydration. The ceramides from Oryza sativa and polysaccharides from Aloe vera increase the concentration of filaggrin and involucrin, two key proteins that participate in building the corneocyte cytosol, the cornified envelope, and the links between corneocytes. Oryza sativa ceramides and Aloe vera polysaccharides also upregulate the gene expression of aquaporin-3, a water/glycerol-transporting protein in the skin, which plays an important role in skin hydration, elasticity and integrity. 3. Anti-inflammatory and immunomodulatory actions: Several cytokines contribute to efficient skin barrier formation by influencing the composition of the lipid envelope, cell–cell adhesion, and the cornification process. Deregulated cytokine expression in the skin can weaken barrier function and thus aggravate the inflammatory response. Althea® (lotion)
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