Benzalkonium Chloride Reckitt Benckiser 0.20%w/w Cutaneous Spray solution

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

BENZALKONIUM CHLORIDE

Disponible depuis:

Reckitt Benckiser Ireland Ltd

Code ATC:

D08AJ

DCI (Dénomination commune internationale):

BENZALKONIUM CHLORIDE

Dosage:

0.20 percent weight/weight

forme pharmaceutique:

Cutaneous spray, solution

Type d'ordonnance:

Product not subject to medical prescription

Domaine thérapeutique:

Quaternary ammonium compounds

Statut de autorisation:

Not marketed

Date de l'autorisation:

2009-11-20

Notice patient

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

Résumé des caractéristiques du produit

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)