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Silica gel, also referred to as silicon dioxide or synthetic amorphous silica (SAS), is listed by the FDA in the United States as generally recognized as safe (GRAS), meaning it can be added to food products without needing approval. Silica is allowed to be added to food in the US at up to 2% as permitted under 21 CFR 172.480.
Medical grade silicones are silicones tested for biocompatibility and are appropriate to be used for medical applications. [1] In the United States, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates devices implanted into the body.
Some additives and gelators added into the formulation may cause irritation problems, [5] [8] such as skin irritation, dermatitis or allergic conditions. [2] The increased water content in gels increases the chances of microbial or fungal attack, [ 5 ] [ 8 ] which may contaminate the gel, making it unsuitable for use.
Unlike its previously approved product for small nicks and cuts, the new gel, Traumagel, can be used for life-threatening injuries, CEO and co-founder Joe Landolina told Reuters.
A gel formulation of the drug has been approved by the U.S. Food and Drug Administration (FDA) [3] and by the European Medicines Agency (EMA) [4] for the topical treatment of actinic keratosis. Two different strengths of the gel have been approved for use on either the face and scalp (0.015%) or the trunk and extremities (0.05%), respectively. [5]
(Reuters) -The U.S. Food and Drug Administration has approved Verrica Pharmaceuticals Inc's treatment of a viral skin infection in adults and children aged 2 years and above, the company said on ...