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

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
BENZALKONIUM CHLORIDE
Available from:
Reckitt Benckiser Ireland Ltd
ATC code:
D08AJ
INN (International Name):
BENZALKONIUM CHLORIDE
Dosage:
0.20 percent weight/weight
Pharmaceutical form:
Cutaneous spray, solution
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Quaternary ammonium compounds
Authorization status:
Not marketed
Authorization number:
PA0979/049/001
Authorization date:
2009-11-20

Health Products Regulatory Authority

26 October 2018

CRN008L42

Page 1 of 6

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

Contains the excipient propylene glycol Ph Eur 2.080% w/w

For a 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

Health Products Regulatory Authority

26 October 2018

CRN008L42

Page 2 of 6

Table. Surface area coverage with a full spray of product.

Distance

(cm)

Weight

(mg)

Surface Area (cm

Product Dispensed

per Surface Area

(mg/cm

Amount of BKC

Dispensed per

Surface Area (mg)

13.2

13.1

0.026

15.1

11.5

0.023

17.7

0.020

19.1

0.018

22.4

0.015

Table. Volume and weight calculations per spray or per ml.

ml per Spray

Mg Product per Spray

Mg BKC per Spray

Mg BKC per ml of

Product

0.1722

172.96

0.3415

1.9837

The product is not intended to improve wound healing or be used to improve

wound healing

4.3 Contraindications

Do not use on children of 1 years of age or under.

People with known hypersensitivity to Benzalkonium chloride or any of the excipients

should not use Benzalkonium Chloride Reckitt Benckiser 0.20%w/w Cutaneous Spray

solution.

4.4 Special warnings and precautions for use

Label Warning: For external use only. Do not use around the eyes or genitalia or ears,

in the mouth or over large areas of the body that exceed 5% of the total body

surface area (5% is estimated to reflect minor wounds of both knees and elbows). Do

not inhale. In the case of accidental eye contact the eye should be irrigated with

copious amounts of cold water.

This medicinal product contains propylene glycol and may cause skin irritation.

Benzalkonium chloride may be deactivated when used with soap or any other

surfactants.

4.5 Interaction with other medicinal products and other forms of interactions

No specific drug interaction studies have been undertaken; therefore, we cannot

recommend the use ofBenzalkonium Chloride Reckitt Benckiser 0.20%w/w Cutaneous

Spray solution with any other topical products.

Health Products Regulatory Authority

26 October 2018

CRN008L42

Page 3 of 6

4.6 Fertility, pregnancy and lactation

For Benzalkonium Chloride no clinical data on exposed pregnancies are available.

Animal studies do not indicate direct or indirect harmful effects with respect to

pregnancy, embryonal/foetal development, parturition or postnatal development.

The potential risk for humans is unknown.

Use during pregnancy and lactation is not expected to be associated with harmful

effects as cutaneous absorption is minimal. In order to avoid ingestion by a breast

fed child, application to the breasts during lactation is not advised

4.7 Effects on ability to drive and use machines

Benzalkonium Chloride Reckitt Benckiser 0.20%w/w Cutaneous Spray solution has no

influence on the ability to drive and use machines.

4.8 Undesirable effects

Post-marketing experience shows no adverse experiences specific to the topical

application ofBenzalkonium Chloride Reckitt Benckiser 0.20%w/w Cutaneous Spray

solution; adverse experiences have been limited to those that are typically reported

for topical antiseptics. Additional effects may occur. In general, the adverse reactions

rate for topical antiseptics is very rare (<1/10,000).

Skin and subcutaneous tissue disorders:

Very Rare: skin dystrophy, acrodermatitis, exacerbation of eczema, contact

dermatitis, alopecia or rash.

General disorders and administration site disorders:

Very Rare: (< 1/10,000) signs and symptoms of systemic allergic reactions, including

papular rash, pruritus or rash.

Very Rare:

local site reactions including application site fissure, a, skin irritation, skin

burning sensation, erythema, skin discoloration or skin exfoliation

4.9 Overdose

Due to Benzalkonium Chloride low absorption into the systemic circulation following

both oral and cutaneous application, its acute toxicity is very low and it is unlikely

that any toxic effects would be seen in humans following either cutaneous dosing

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

recommended or accidental ingestion. If necessary use a clean tissue or cotton wool

to wipe up any excess liquid.

Health Products Regulatory Authority

26 October 2018

CRN008L42

Page 4 of 6

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: D08 AJ01 Group: Antiseptics and Disinfectants. Quaternary ammonium

compounds.

Benzalkonium chloride is a quaternary ammonium compound which has been used

for many years as a surfactant and antiseptic/disinfectant. It is known to be

bactericidal in low concentrations (typically between 0.1 and 0.2%) to a wide range of

Gram-positive and Gram-negative bacteria.

Benzalkonium chloride kills (a log 5 reduction) Staphylococcus aureus and

beta-hemolytic Streptococci (e.g., Streptococcus pyogenes) in 1 minute, and

Pseudomonas aeruginosa in 5 minutes

Table. In vitro bactericidal effects Benzalkonium Chloride

Reckitt Benckiser 0.20%w/w Cutaneous Spray solution.

Strain

Contact

time

Medium Result

Criteria

met

Corynebacterium

xerosis

Staphylococcus

epidermidis

Proteus

vulgaris

Streptococcus

pyogenes

Staphylococcus

aureus (MRSA)

Enterococcus

faecalis (VRE)

5 min

Full

strength

in clean

(0.3) and

dirty

(3.0g/l

bovine

serum

albumin)

>5.0 log

reduction

EN 1276

Staphylococcus

aureus

Corynebacterium

xerosis

Staphylococcus

epidermidis

Proteus

vulgaris

Streptococcus

pyogenes

Staphylococcus

1 min

Full

strength

in clean

(0.3) and

dirty

(3.0g/l

bovine

serum

albumin)

>5.0 log

reduction

EN 1276

Health Products Regulatory Authority

26 October 2018

CRN008L42

Page 5 of 6

aureus (MRSA)

Enterococcus

faecalis (VRE)

Note: EN 1276 is designed to evaluate the antimicrobial efficacy of disinfectant

products intended for use in food, industrial, domestic and institutional areas. It can

be used to assess efficacy. A Five log reduction of all organisms in 5 minutes is

required to pass the EN1276.

5.2 Pharmacokinetic properties

Quaternary ammonium compounds such as Benzalkonium chloride are only

absorbed to a very small extent through human skin.

5.3 Preclinical safety data

The low level of Benzalkonium chloride in the product, coupled with its low level of

absorption from intact and broken skin, make it unlikely that any significant systemic

toxic effects would arise from its use. There is evidence that it can have an irritant

effect on mucous membranes.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Propylene glycol

Sodium dihydrogen phosphate dihydrate

Disodium hydrogen phosphate dodecahydrate

Mild Pine fragrance

Disodium edetate, dihydrate

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

10ml polypropylene bottle has a shelf life of 2 years.

100ml HDPE bottle has a shelf life of 3 years.

6.4 Special precautions for storage

No special storage conditions

Health Products Regulatory Authority

26 October 2018

CRN008L42

Page 6 of 6

6.5 Nature and contents of container

Polypropylene container, spray pump, with a polypropylene co-polymer overcap

packed into polyethylene terephthalate (PET) blister and carton envelope.

The pack size is 10 ml.

HDPE container, spray pump, with a polypropylene co-polymer overcap.

The pack size is 100ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

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

not be disposed of via wastewater or household waste. Any unused medicinal

product or waste material should be disposed of in accordance with local

requirements

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Ltd

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0979/049/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 20

November 2009

Date of first renewal: 1

September 2014

10 DATE OF REVISION OF THE TEXT

October 2018

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