Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Otic Drug Monograph Modified To Include Flammability Warning

This article was originally published in The Tan Sheet

Executive Summary

FDA is amending the final monograph for topical otic drugs to require that labeling of OTC products for drying water-clogged ears contain a flammability warning. The agency also has established mandatory directions and warnings that must appear in the labeling of ear drying aids.

You may also be interested in...

"Ear Drying Aids" Monograph Status Proposed By FDA

FDA is proposing to amend the topical otic drug products final monograph to include "ear drying aid" products with the active ingredient 95% isopropyl alcohol in a 5% anhydrous glycerin base, the agency announces in the Aug. 17 Federal Register. Such products currently are being marketed under a partial stay of a final rule classifying otic products as not generally recognized as safe and effective for OTC use.

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts