Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

hydrocortisone acetate pramoxine hcl

CompanyPadagis Israel Pharmaceuticals Ltd (DUNS: 600093611)

Effective Date

November 29, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrocortisone acetate(1 g in 100 g)

Hydrocortisone Acetate/Pramoxine Hydrochloride(1 g in 100 g)

Products (1)

hydrocortisone acetate pramoxine hcl

NDC Product Code

45802-144

Application Number

ANDA085368

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

March 15, 2018

Ingredients

POLYOXYL 40 STEARATEInactive

Code: 13A4J4NH9IClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

CETYL ALCOHOLInactive

Code: 936JST6JCNClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM SORBATEInactive

Code: 1VPU26JZZ4Class: IACT

TRIETHANOLAMINE LAURYL SULFATEInactive

Code: E8458C1KAAClass: IACT

SORBIC ACIDInactive

Code: X045WJ989BClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Hydrocortisone acetateActive

Code: 3X7931PO74Class: ACTIBQuantity: 1 g in 100 g

ISOPROPYL PALMITATEInactive

Code: 8CRQ2TH63MClass: IACT

Hydrocortisone Acetate/Pramoxine HydrochlorideActive

Code: 88AYB867L5Class: ACTIBQuantity: 1 g in 100 g

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy