Dettol Antiseptic Wash

1. Name Of The Medicinal Product

Dettol Antiseptic Wash.

2. Qualitative And Quantitative Composition

Active Constituent	% w/v
Benzalkonium chloride	0.198

3. Pharmaceutical Form

Topical Spray.

4. Clinical Particulars

4.1 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 Contraindications

None known.

4.4 Special Warnings And 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. Pharmacological Properties

5.1 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 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

The product contains the following excipients:

Propylene glycol

Sodium acid phosphate

Sodium phosphate

Mild pine perfume

Disodium edetate

Softened water

6.2 Incompatibilities

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

6.3 Shelf Life

Two years at 30°C.

6.4 Special Precautions For Storage

Store below 30°C.

6.5 Nature And Contents 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 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Reckitt Benckiser (UK) Limited

103-105 Bath Road

Slough, SL1 3UH

United Kingdom

8. Marketing Authorisation Number(S)

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