OEL Fastrac Catalog

Peppermint oil is a natural product extracted from the stem, leaves, and flowers of Mentha piperita L. plant and is used as an essential oil. It is indicated for the over the counter (OTC) use for the symptomatic relief of gastrointestinal tract spasms, flatulence, abdominal pain and irritable bowel syndrome (IBS), for the temporary relief of itching associated with insect bites, eczema, minor burns, skin irritations, minor cuts, scrapes, and atopic dermatitis, for the temporary symptomatic relief of mild joint and muscle pain, and for the temporary relief of tension-type headache. Peppermint oil is also used as a flavoring agent in foods and fragrance in hygienic and cosmetic products.

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.

Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Peppermint Oil, just click the ADD TO CART button.

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