País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
BENZALKONIUM CHLORIDE
Reckitt Benckiser Ireland Ltd
D08AJ
BENZALKONIUM CHLORIDE
0.20 percent weight/weight
Cutaneous spray, solution
Product not subject to medical prescription
Quaternary ammonium compounds
Not marketed
2009-11-20
PACKAGING LEAFLET: INFORMATION FOR THE USER BENZALKONIUM CHLORIDE RECKITT BENCKISER 0.20%W/W CUTANEOUS SPRAY, SOLUTION (BENZALKONIUM CHLORIDE) FOR EXTERNAL USE ONLY IMPORTANT INFORMATION ABOUT THE INGREDIENTS OF BENZALKONIUM CHLORIDE RECKITT BENCKISER 0.20%W/W CUTANEOUS SPRAY This product contains benzalkonium chloride 0.20% w/w as the active ingredient and 20.8 mg propylene glycol in each 100 ml, which may cause skin irritation. READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Benzalkonium Chloride Reckitt Benckiser 0.20%w/w Cutaneous Spray Solution carefully to get the best results from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. YOU MUST CONTACT YOUR DOCTOR IF SYMPTOMS WORSEN OR DO NOT IMPROVE AFTER 5 DAYS. IN THIS LEAFLET : 1. WHAT BENZALKONIUM CHLORIDE RECKITT BENCKISER 0.20W/W CUTANEOUS SPRAY SOLUTION IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE BENZALKONIUM CHLORIDE RECKITT BENCKISER 0.20W/W CUTANEOUS SPRAY SOLUTION 3. HOW TO USE BENZALKONIUM CHLORIDE RECKITT BENCKISER 0.20W/W CUTANEOUS SPRAY SOLUTION 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BENZALKONIUM CHLORIDE RECKITT BENCKISER 0.20%W/W CUTANEOUS SPRAY SOLUTION 6. FURTHER INFORMATION 1. WHAT BENZALKONIUM CHLORIDE RECKITT BENCKISER 0.20%W/W CUTANEOUS SPRAY SOLUTION IS AND WHAT IT IS USED FOR Benzalkonium Chloride Reckitt Benckiser 0.20%w/w Cutaneous Spray Solution is used to cleanse fresh minor wounds and to get rid of common bacteria associated with infection of minor wounds. The product is not intended to improve wound healing or be used to improve wound healing. It must not be used for large or serious wounds and it is intended for occasional, localised, short-term use only. It should be used only once in 24 hours. It is re Leer el documento completo
Health Products Regulatory Authority 20 April 2021 CRN009ZVZ Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benzalkonium Chloride Reckitt Benckiser 0.20%w/w Cutaneous Spray solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzalkonium Chloride 0.20%w/w Excipients with known effect: propylene glycol (E1520) Ph. Eur. 2.080% w/w Fragrances containing allergens (in Mild Pine fragrance) For the full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Cutaneous Spray, Solution (Topical Spray) Product is a clear colourless liquid with slight pine odour 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the antiseptic cleansing of minor wounds 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For Cutaneous use FOR ADULTS AND CHILDREN OVER 12 MONTHS OF AGE: For occasional, localised, short-term use only. To be applied to fresh minor wounds to eliminate common bacteria associated with infection of minor wounds. The product should be sprayed to cover the entire wound and can be re-applied if the wound is reopened For adults and children over 6 years of age: Spray a full dose (1 to 2 sprays) once ONTO each wound and leave for five minutes. If necessary use a clean tissue or cotton wool to wipe up any excess liquid. For children aged between 1 and 6 years of age: Please seek the advice of a pharmacist or healthcare professional prior to use if you have any concerns. Spray once (1 spray) ONTO each wound (CAN ONLY BE APPLIED TO A MAXIMUM OF 4 WOUNDS AT A TIME) and leave for five minutes. If necessary use a clean tissue or cotton wool to wipe up any excess liquid. This medicinal product is for use once in 24hours and for a maximum of 3 – 5 days. It should not be used on a continuous basis If you have concerns about your symptoms or your symptoms get worse, please contact a healthcare professional TABLE. SURFACE AREA COVERAGE WITH A FULL SPRAY OF PRODUCT. Distance (cm) Weight (mg) Surface Area (cm 2 ) Product Dispensed per Surface Area (mg/cm 2 ) Amount of BKC Dispensed per Surface Area (mg) Leer el documento completo