Summary Safety Review - Topical Antiseptic Non-Prescription Chlorhexidine Products - Assessing the Potential Risk of Serious Allergic Reactions (hypersensitivity reactions)

This safety review was carried out to look at the potential link between non-prescription topical antiseptic chlorhexidine products and serious allergic reactions, and to determine if there is a need for additional labelling requirements. Symptoms of a serious allergic reaction, including anaphylaxis, may include itchy hives with swelling of the face, eyes, lips, mouth or throat; difficulty breathing; throat tightness or hoarseness; and fainting. An anaphylactic reaction is a serious and potentially life-threatening hypersensitivity reaction.