WARTICON Topical cream Ref.[8350] Active ingredients: Podophyllotoxin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, IRELAND

Product name and form

Warticon 0.15% w/w Cream.

Pharmaceutical Form

Topical Cream.

A homogenous white cream.

Qualitative and quantitative composition

Podophyllotoxin 1.5 mg/g (0.15% w/w).

Excipients with known effect:

Methyl parahydroxybenzoate (E218) 0.100% w/w
Propyl parahydroxybenzoate (E216) 0.030% w/w
Sorbic acid 0.120% w/w
Stearyl alcohol 2.000% w/w
Cetyl alcohol 2.000% w/w
Butyl hydroxyanisole (BHA) (E320) 0.015% w/w

For the full list of excipients, see section 6.1.

Active Ingredient Description
Podophyllotoxin

Podophyllotoxin is a metaphase inhibitor in dividing cells binding to at least one binding site on tubulin. Binding prevents tubulin polymerisation required for microtubule assembly. At higher concentrations, podophyllotoxin also inhibits nucleoside transport through the cell membrane.

List of Excipients

Purified water
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Sorbic acid
Phosphoric acid
Stearyl alcohol
Cetyl alcohol
Isopropyl myristate
Paraffin, liquid
Triglycerides, medium chain
Butyl hydroxyanisole (BHA) E320
Macrogol–7 stearyl ether
Macrogol–10 stearyl ether

Pack sizes and marketing

A collapsible aluminium tube with imperforate nozzle membrane and internally coated with a protective lacquer. Tube cap of polyethylene with a spike on the upper end aimed to perforate the membrane when opening the tube for the first time. Size 5g and 10g.

Marketing authorization holder

Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, IRELAND

Marketing authorization dates and numbers

PL 35104/0023

Date of first authorisation: 26th April 1999
Date of last renewal: 17th January 2010

Drugs

Drug Countries
WARTICON Ireland, Malta, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.