Regulatory PathRegulatory requirements compared

Active substances

Hydrocortisone + Pramoxine

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
PRAMOSONE0.5%;1%cream · topicalLEGACYPrescription13 Aug 1976
PRAMOSONE1%;1%cream · topicalLEGACYPrescription7 Jan 1977
PRAMOSONE2.5%;1%lotion · topicalLEGACYPrescription5 Jun 1978
PRAMOSONE1%;1%lotion · topicalLEGACYPrescription5 Jun 1978
PROCTOFOAM HC1%;1%aerosol, metered · topicalMYLAN SPECIALITY LPPrescription26 Jul 1978
EPIFOAM1%;1%aerosol, metered · topicalMYLAN SPECIALITY LPPrescription19 Dec 1979
PRAMOSONE0.5%;1%lotion · topicalFERNDALE LABSDiscontinued13 Nov 1973
HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%1%;1%aerosol, metered · topicalGENUSDiscontinued17 May 1988

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PRAMOX HC CREAM007709571 %; 1 %CREAM · TOPICALDERMTEK PHARMA INC
PRAMOX HC LOTION019542101 %; 1 %LOTION · TOPICALDERMTEK PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPROCTOFOAM-HC 1%-1% FOAM$19.38171per GM23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.