Source: Health Products and Food Branch (CA) Revision Year: 2012
NYDA must not be used in people with known allergies (hypersensitivity) to any of its ingredients. For a complete ingredient listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
NYDA should not be used in pregnant or breast-feeding women or in children under the age of two because of lack of experience in these patient groups.
For external use only.
Patients should be warned to not use NYDA near the eyes or mucosa membranes (nose or mouth). If product gets into their eyes, patients should immediately rinse for 10-15 minutes with water.
Patients should be warned to avoid inhaling or ingesting NYDA.
Patients should be told that NYDA could react with certain hair care and hair tinting products. Patients should be told to keep away from any open flame or intense heat source which uses an open flame and to keep away of any sources of ignition and not to smoke while using this product as the mixture is volatile. If NYDA is spilled accidentally, there is a danger of slipping. Spillages should therefore be cleaned up immediately.
No clinical studies have been performed in pregnant women; therefore NYDA should be used with caution.
No clinical studies have been performed in nursing women; therefore NYDA should be used with caution.
Clinical studies have been performed in children; therefore NYDA can be used with children from ages 2 and up.
No clinical studies have been performed in elderly patients; however the use of NYDA should not be of concern.
In a clinical study, 145 subjects were treated with either NYDA or with a permethrin-based product. The number of subjects experiencing any adverse events was similar in both groups.
In the NYDA group, 29 adverse events were reported in 25 participants; all but two of them were classified as being unrelated to the treatment (e.g., superficial wound after a fall, otitis externa following swimming in a pool). Two subjects in the NYDA group experienced ocular irritation after treatment when the product entered the eyes. The irritation resolved spontaneously in both cases after washing the eyes with clean water.
In a large Postmarketing Surveillance Study in Germany, (833 patients) a total of six adverse events were reported; these included four occurrences of a bothersome hair odour and one occurrence each of a headache and a burning sensation in the eyes.
No drug interaction studies have been conducted for NYDA.
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