Please note, this OEL/ADE monograph also applies to Oxymetazoline hydrochloride (CAS RN 2315-02-8). Oxymetazoline is a direct acting sympathomimetic agent (alpha1A adrenoceptor agonist) indicated as a topical decongestant and as a topical treatment of persistent facial erythema (redness) associated with rosacea in adults and treatment of acquired blepharoptosis in adults. Oxymetazoline is also indicated in the temporary relief of ocular redness caused by irritation. In combination with tetracaine hydrochloride, oxymetazoline is indicated for regional anesthesia when performing a restorative procedure on teeth numbers 4 to 13 and A to J in adults and children who weigh 40 kg or more,
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Oxymetazoline, just click the ADD TO CART button.
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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.