CRYSTACIDE CREAM 1%

CRYSTACIDE CREAM 1%

Active ingredient

Hydrogen peroxide 1.0% (w/w)

1g of cream contains 10mg of hydrogen peroxide at a concentration of 1%.

Cream.

Crystacide cream is intended for topical application for the treatment of primary and secondary superficial skin infections caused by organisms sensitive to hydrogen peroxide.

Adults, elderly and children

Crystacide cream is applied 2-3 times daily on the infected skin area. The treatment period should not exceed 3 weeks. A dry film will appear on the skin after application, this can be washed off with water.

Hypersensitivity to the active substance or any of the excipients.

Contact with the eyes should be avoided. Crystacide Cream should not be used on large or deep wounds and should not be applied to healthy skin. Hydrogen peroxide can bleach fabric.

Salicylic acid is a mild irritant and can cause dermatitis.

Crystacide Cream also contains propylene glycol which may cause skin irritation.

Crystacide cream is incompatible with iodine, permanganates and other stronger oxidising agents.

To be used under medical guidance.

Not applicable.

A mild sensation of burning may be experienced for a short time after application.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Not applicable

ATC Code: D0 8A

Antiseptics and Disinfectants

Hydrogen peroxide is a well-known antiseptic agent, and is effective against a majority of pathogenic micro-organisms.

In-vitro pharmacology studies have shown that hydrogen peroxide has both activity against a wide variety of micro-organisms, and is a potent antibacterial agent with effect against Gram-positive as well as Gram-negative bacteria.

In-vitro studies have shown that the bactericidal activity of Crystacide cream 1% is equal in effect compared with a 1% aqueous solution of hydrogen peroxide, and the duration of action is longer for the cream.

There are no known pathogenic bacteria or fungi that develop resistance to hydrogen peroxide.

Reports on the rate of absorption, distribution and excretion of hydrogen peroxide after oral administration are sparse. In the absence of stabilising agent, hydrogen peroxide gradually decomposes to oxygen and water. The decomposition is rapid in the presence of the endogenous enzyme catalase or peroxidase.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Glyceryl monolaurate

Glyceryl monomyristate

Macrogolstearate 5000

Propylene glycol

Citric acid anhydrous

Sodium hydroxide

Sulphuric acid, 1M

Sodium oxalate

Salicylic acid

Disodium edetate

Sodium pyrophosphate

Sodium stannate

Purified water

Iodine, permanganates and other stronger oxidising agents.

Unopened: 2 years

After first opening the container: 28 days

Store below 25°C, in a dry place.

Crystacide cream is filled into polyethylene tubes pigmented with titanium dioxide, and fitted with polypropylene caps. Each tube is subsequently packed in a unit, printed boxboard carton, in pack sizes of 5g, 10g, 25g and 40g.

Not applicable

Reig Jofre UK Limited

Unit 9A Caddsdown Business Support Centre

Caddsdown Industrial Park

EX39 3DX Bideford, Devon

United Kingdom

PL 44095/0011

17/01/2006

04/03/2019