Cetrimide Adverse reactions have been reported following repeated application of creams containing more than 1% cetrimide. Topical products containing more than 1% cetrimide will not be approved for registration unless appropriate supporting clinical efficacy and safety data are provided. Chest rubs The use of chest rubs will not be accepted for the treatment of bronchial conditions. The only indications that will be accepted for chest rubs containing ingredients such as eucalyptus oil, menthol, camphor and other aromatics are: (or similar wording). May relieve the nasal congestion of colds and make breathing easier The directions for use of rubs should include the following statement: Do not apply to infants under 12 months of age unless on the advice of a doctor or pharmacist. Rub on the chest and/or the throat. Do not use on the face or anywhere near or in the eyes or nostrils. See also , and . Chlorhexidine Adverse allergic reactions have been reported for products containing chlorhexidine for use on oral mucosal surfaces. Therefore the labels of products containing chlorhexidine for application to mucous membranes should include a prominent statement consistent with the following: *Warning – This product contains chlorhexidine. Severe allergic reactions can Stop use if this occurs.
Cetrimide Adverse reactions have been reported following repeated application of creams containing more than 1% cetrimide. Topical products containing more than 1% cetrimide will not be approved for registration unless appropriate supporting clinical efficacy and safety data are provided. Chest rubs The use of chest rubs will not be accepted for the treatment of bronchial conditions. The only indications that will be accepted for chest rubs containing ingredients such as eucalyptus oil, menthol, camphor and other aromatics are: May relieve the nasal congestion of colds and make breathing easier (or similar wording). The directions for use of rubs should include the following statement: Do not apply to infants under 12 months of age unless on the advice of a doctor or pharmacist. Rub on the chest and/or the throat. Do not use on the face or anywhere near or in the eyes or nostrils. See also , and . Chlorhexidine Adverse allergic reactions have been reported for products containing chlorhexidine for use on oral mucosal surfaces. Therefore the labels of products containing chlorhexidine for application to mucous membranes should include a prominent statement consistent with the following: *Warning – This product contains chlorhexidine. Severe allergic reactions can Stop use if this occurs.
consult-otc-argom-111128-app5-product-specific.docx