This information is intended for use by health professionals

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. 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

Posology

For adults and children:

To be used once in any 24 hour period. Repeat as necessary every 24 hours for up to a maximum of 5 days.

Not for use in children under 1 year of age.

Method of administration

Topical use only.

Spray directly onto the wound until it is visibly wet and clean and any dirt or debris has been washed away. If necessary use a clean tissue or cotton wool to wipe away any excess liquid. Repeat as necessary.

4.3 Contraindications

Hypersensitivity to benzalkonium chloride or to any of the excipients listed in section 6.1

4.4 Special warnings and precautions for use

Label Warning: For external use only.

Do not use around the eyes or ears or the genitalia, in the mouth or over large areas of the body that exceed 5% of the total body surface.

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.

The use of this spray with any other topical product is not recommended.

4.5 Interaction with other medicinal products and other forms of interaction

Benzalkonium Chloride may be deactivated if used with soap or other surfactants

4.6 Fertility, pregnancy and lactation

Pregnancy:

The product is considered safe to use during pregnancy. Use during pregnancy is not expected to be associated with harmful effects as cutaneous absorption is minimal.

Breast feeding:

No effects on the breast fed newborn/infant are anticipated since the systemic exposure of the breast feeding woman to benzalkonium chloride is negligible.

In order to avoid possible ingestion by a breast fed child, application to the breast during lactation is not advised.

Fertility:

No known effects.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Post-marketing data indicates no specific adverse events of concern for this product.

Typical adverse events associated very rarely with topical antiseptics are given below, tabulated by system organ class and frequency.

Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class

Frequency

Adverse Event

Skin and Subcutaneous Tissue Disorders

Not known

Skin dystrophy, acrodermatitis, exacerbation of eczema, contact dermatitis, alopecia or rash.

General Disorders and Administration Site Disorders

Not known

Signs and symptoms of systemic allergic reactions including papular rash, pruritis or rash.

Local site reactions including application site fissure, skin irritation, skin burning sensation, erythema, skin discolouration or skin exfoliation.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Symptoms

Unlikely to have any toxic effect.

Management

Treat symptomatically.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Quaternary ammonium compounds -benzalkonium;

ATC Code: D08AJ01

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 (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 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 Healthcare (UK) Limited

103-105 Bath Road

Slough, SL1 3UH

United Kingdom

8. Marketing authorisation number(s)

PL 00063/0765

9. Date of first authorisation/renewal of the authorisation

4 November 2002

10. Date of revision of the text

27/02/2020