Skip to Content

DETTOL ANTISEPTIC WASH

Active substance(s): BENZALKONIUM CHLORIDE / BENZALKONIUM CHLORIDE / BENZALKONIUM CHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Dettol Antiseptic Wash

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Active Constituent Benzalkonium chloride % w/v 0.198

3.

PHARMACEUTICAL FORM Topical Spray.

4. 4.1.

CLINICAL PARTICULARS Therapeutic Indications For the antiseptic cleansing of minor wounds such as cuts and skin grazes, insect bites and stings, small burns and scalds.

4.2.

Posology and Method of Administration For adults and children: Spray onto the wound until it is visibly wet and clean, and any dirt and debris has been washed away. If necessary use a clean tissue or cotton wool to wipe up any excess liquid. Repeat as necessary.

4.3.

Contra-Indications None known.

4.4.

Special Warnings and Special Precautions for Use Label Warning: For external use only. Do not use around the eyes or ears, in the mouth or over large areas of the body. Do not inhale. In the case of

accidental eye contact, the eye should be irrigated with copious amounts of cold water.

4.5.

Interaction with other Medicinal Products and other Forms of Interaction None known.

4.6.

Pregnancy and Lactation Can be used.

4.7.

Effects on Ability to Drive and Use Machines None known.

4.8.

Undesirable Effects None known.

4.9.

Overdose Not applicable.

5. 5.1.

PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties 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 to a wide range of Gram-positive and Gram-negative bacteria.

5.2.

Pharmacokinetic Properties

Quaternary ammonium compounds such as benzalkonium chloride are only absorbed to a very small extent through human skin.

5.3.

Pre-clinical 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.
6.1.

PHARMACEUTICAL PARTICULARS
List of excipients
The product contains the following excipients: Propylene glycol Sodium acid phosphate Sodium phosphate Mild pine perfume (Efficiently 44) Disodium edetate Purified water

6.2.

Incompatibilities Benzalkonium chloride may be deactivated when used with soap or other surfactants.

6.3.

Shelf-Life Two years at 30C.

6.4.

Special Precautions for Storage Store below 30C.

6.5.

Nature and Content of Container

The liquid is contained in a natural HDPE container with a finger action spray pump for administration. The pump head is protected by a clear, polypropylene co-polymer overcap. The pack size is 100 ml.

6.6.

Instructions for Use, Handling and Disposal Not applicable.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser (UK) Limited 103-105 Bath Road Slough, SL1 3UH United Kingdom

8.

Marketing Authorisation Number PL 19718/0003

9.

Date of First Authorisation/Renewal of the Authorisation 4 November 2002

10

DATE OF REVISION OF THE TEXT
22/11/2010

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide