Crystacide 1% w/w Cream 40g

Cream.

4.1 Therapeutic indications Crystacide cream is intended for topical application for the treatment of primary and secondary superficial skin infections caused by organisms sensitive to hydrogen peroxide.4.2 Posology and method of administration *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.4.3 Contraindications Hypersensitivity to the active substance or any of the excipients.4.4 Special warnings and precautions for use 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.4.5 Interaction with other medicinal products and other forms of interaction Crystacide cream is incompatible with iodine, permanganates and other stronger oxidising agents.4.6 Pregnancy and lactation To be used under medical guidance.4.7 Effects on ability to drive and use machines Not applicable.4.8 Undesirable effects 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.4.9 Overdose Not applicable

5.1 Pharmacodynamic properties **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.5.2 Pharmacokinetic properties 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.5.3 Preclinical safety data There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.1 List of excipients 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 water6.2 Incompatibilities Iodine, permanganates and other stronger oxidising agents.6.3 Shelf life Unopened: 2 years After first opening the container: 28 days6.4 Special precautions for storage Store below 25ºC, in a dry place.6.5 Nature and contents of container 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.6.6 Special precautions for disposal and other handling Not applicable