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


OTC diaper rash products

This article was originally published in The Tan Sheet

Executive Summary

Compliance bulletin issued to the field on May 21 notes that "the use of any active external analgesic ingredient and/or topical antifungal ingredient in a product offered to treat and/or prevent diaper rash introduced . . . into interstate commerce" after June 17 without an approved NDA will be in violation of the FD&C Act. The final rules for external analgesics and topical antifungals used for diaper rash were published Dec. 18, 1992 and go into effect on June 18. The bulletin lists several products for diaper rash, including Fisons' Caldesene Medicated Powder and Ointment, Fleming's Impregon, Sween's Sween Cream, Macsil's Balmex Baby Powder, and Innotek's Bottom Better.

You may also be interested in...

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC





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