OEL Fastrac Catalog

The herb Centella asiatica has been used in traditional Asian medicine for many years, especially for treating dermatological conditions, including small wounds, scratches, and burns, and as a hypertrophic wound-healing agent and an anti-inflammatory agent, particularly in eczema. However, gotu kola, Centella asiatica extract, and an ointment that contains Centella asiatica extract (Madecassol® ointment) are not Food and Drug Administration (FDA)-approved drug products. Centella asiatica extract is indicated for the treatment of first-degree burns, radiation burns, skin ulcers, and second-degree burns. Additionally, it is used for the symptomatic treatment of itching as a combination product with neomycin and for the therapy and treatment of damaged skin as a combination product with adenosine and acetyl hexapeptide-3. It is indicated for symptoms of venous insufficiency and capillary fragility, such as heavy legs, swelling, and edema in the lower limbs. The Centella asiatica preparations used in conventional medicine are available as tablets and drops for oral administration, as ointments, cream, gel, shampoo, and powder for topical administration, as injections for subcutaneous (SC) and intramuscular (IM) administration, and as external or internal homeopathic preparations.

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 Centella asiatica Extract, just click the ADD TO CART button.

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