Inhalation Warnings For Aerosolized Antip/Deo Is Not Redundant – FDA
This article was originally published in The Rose Sheet
Executive Summary
The need for two inhalation warnings on labeling for aerosolized dosage forms in the OTC Antiperspirant Drug Products Final Monograph is justified, FDA says in a Feb. 17 letter to the Cosmetic, Toiletry and Fragrance Association, partially denying a citizen petition submitted by the trade group
You may also be interested in...
Antiperspirant Labeling Determined Appropriate In FDA Petition Denial
Modified labeling is not necessary for OTC antiperspirants because they can readily incorporate the information required under the final monograph in the "Drug Facts" format, FDA says in a letter to the Cosmetic, Toiletry and Fragrance Association
FDA Antiperspirant Monograph Partial Stay Permits Enhanced Duration
Under a partial stay of the OTC Antiperspirant Monograph, products claiming enhanced duration up to 48 hours will be permitted on the market while FDA reviews new data, the agency says in an Oct. 15 Federal Register notice
Antiperspirant Duration Claims Limit Revision Sought By CTFA
FDA should revoke the provision in the OTC Antiperspirant Drug Products Final Monograph limiting duration of efficacy claims to 24 hours, the Cosmetic, Toiletry and Fragrance Association contends in a July 8 petition to the agency