Warts are noncancerous growths on the skin or mucous membranes caused by the human papillomavirus (HPV).
Salicylic acid is the only FDA approved active ingredient at concentrations between 5% and 40% subject to the delivery base like plaster/collodion-like or karaya gum, glycol plaster vehicle.
Since wart removers are considered as OTC drugs, the manufacturers must comply with all drug requirements such as establishment registration, drug listings, cGMP requirements and labeling.
In the labeling, they must include “Wart remover” along with the established name of the drug.
The labels must carry the indications of use, direction of use, warnings and contact phone numbers to call.
Liberty Management Group provides assistance with drug establishment registration, drug listing and label review and US agent service to foreign drug companies.
Sudha S
Regulatory Consultant
Email : office@libertymanagement.us