Active ingredients: Hydrogen peroxide
CRYSTACIDE - 1% cream
Why is Crystacide used? What is it for?
Pharmacotherapeutic group
Disinfectant.
Therapeutic indications
CRYSTACIDE CREMA is formulated for topical application in the treatment of primary and secondary superficial skin infections caused by organisms sensitive to hydrogen peroxide.
Contraindications When Crystacide should not be used
Known hypersensitivity to one or more excipients of the product.
Precautions for use What you need to know before taking Crystacide
Avoid contact with eyes. If the product comes into contact with the eyes, rinse them immediately with plenty of cold water. Hydrogen peroxide can whiten tissues. Salicylic acid is a mild irritant and can cause dermatitis.
Crystacide Cream also contains propylene glycol which can cause skin irritation.
Interactions Which drugs or foods can modify the effect of Crystacide
CRYSTACIDE CREAM is incompatible with iodine, permanganates and other stronger oxidizing agents.
Warnings It is important to know that:
Pregnancy and lactation: Use under medical supervision.
Dose, Method and Time of Administration How to use Crystacide: Posology
CRYSTACIDE CREMA is contained in polyethylene tubes colored with titanium dioxide and fitted with a polypropylene cap. Each tube is contained in a 25 g, 40 g, 10 g, 5 g printed cardboard package.
Use in adults, the elderly and children
CRYSTACIDE CREAM is applied 2-3 times a day on the infected part of the skin. A dry film may appear on the wound which can be removed by washing the area with water.
Duration of treatment
The treatment period should not last for more than 3 weeks.
Side Effects What are the side effects of Crystacide
CRYSTACIDE CREAM is generally well tolerated and is not associated with any serious side effects. However, a slight burning sensation may be felt for a short time after application. In the case of prolonged skin irritation or other undesirable effects even if not described in the package leaflet, the patient is invited to inform their doctor or pharmacist and ask if the application of the drug should be stopped.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Do not use the drug beyond the expiration date indicated on the package.
Other information
Composition
1g of cream contains:
- Active ingredient 10mg hydrogen peroxide.
- Excipients Glyceryl monolaurate, Glyceryl monomyristate, macrogol stearate 5000, Propylene glycol, Citric acid anhydrous, Sodium hydroxide, Sulfuric acid, Sodium oxalate, Salicylic acid, Disodium edetate, Sodium pyrophosphate, Sodium stannate, Purified water.
Pharmaceutical form
Cream.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
Further information on Crystacide can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL
01.0 NAME OF THE MEDICINAL PRODUCT
CRYSTACIDE CREAM ALL "1%
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active principle
1.0% (w / w) hydrogen peroxide.
1 gram of cream contains 10 mg of hydrogen peroxide at a concentration of 1%.
03.0 PHARMACEUTICAL FORM
Cream.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Crystacide cream is formulated for topical application in the treatment of primary and secondary superficial skin infections caused by organisms sensitive to hydrogen peroxide.
04.2 Posology and method of administration
Adults, the elderly and children : Crystacide cream is applied 2-3 times a day on the infected part of the skin. The treatment period should not last for more than 3 weeks. A dry film may appear on the wound which can be removed by washing the area with water.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
Avoid contact with eyes. Crystacide cream should not be used on large or deep wounds, or on healthy skin. Hydrogen peroxide can whiten tissues.
Salicylic acid is a mild irritant and can cause dermatitis.
Crystacide Cream also contains propylene glycol which can cause skin irritation.
04.5 Interactions with other medicinal products and other forms of interaction
Crystacide cream is incompatible with iodine, permanganates and other stronger oxidizing agents.
04.6 Pregnancy and breastfeeding
To be used under medical supervision
04.7 Effects on ability to drive and use machines
Not applicable.
04.8 Undesirable effects
A mild burning sensation may be felt for a short time after application.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "Street address www.aifa.gov.it/responsabili.
04.9 Overdose
Not applicable
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ATC code: D08A.
Antiseptics and disinfectants.
Hydrogen peroxide is a well-known antiseptic substance effective against most pathogenic microorganisms.
In vitro pharmacological studies have shown that hydrogen peroxide is effective against a wide range of microorganisms and is a potent antibacterial effective against Gram positive and Gram negative bacteria.
In vitro studies have shown that the bactericidal activity of Crystacide 1% cream has the same effects as those obtained with the 1% aqueous solution of hydrogen peroxide and that the cream has a longer duration of action.
There are no known pathogenic bacteria or fungi that develop resistance to hydrogen peroxide.
05.2 Pharmacokinetic properties
Data on the rate of absorption, distribution and elimination of hydrogen peroxide after oral administration are limited. In the absence of a stabilizing substance, hydrogen peroxide gradually decomposes into oxygen and water. Decomposition is rapid in the presence of the endogenous catalase or peroxidase enzyme.
05.3 Preclinical safety data
There are no relevant preclinical data for those who carry out the prescription to add to what is already contained in other chapters of the SPC.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Glyceryl monolaurate
Glyceryl monomyristate
Macrogol stearate 5000
Propylene glycol
Anhydrous citric acid
Sodium hydroxide
Sulfuric acid, 1M
Sodium oxalate
Salicylic acid
Disodium edetate
Sodium pyrophosphate
Sodium stannate
Purified water
06.2 Incompatibility
Iodine, permanganates and other stronger oxidizing agents.
06.3 Period of validity
2 years.
After first opening the container: 28 days.
06.4 Special precautions for storage
Store below 25 ° C, in a dry place.
06.5 Nature of the immediate packaging and contents of the package
Crystacide cream is contained in polyethylene tubes colored with titanium dioxide and fitted with a polypropylene cap. Each tube is contained in a printed cardboard package in 5 g, 10 g, 25 g and 40 g formats.
06.6 Instructions for use and handling
Not applicable.
07.0 MARKETING AUTHORIZATION HOLDER
Giuliani S.p.a.
Via Palagi, 2
20129 Milan
08.0 MARKETING AUTHORIZATION NUMBER
5g tube-AIC: 034220018
10g tube-AIC: 034220020
25g tube-AIC: 034220032
40g tube-AIC: 034220044
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
1 April 1999/17 January 2006
10.0 DATE OF REVISION OF THE TEXT
June 20, 2016
