Dettol Antiseptic Wash
SUMMARY OF PRODUCT CHARACTERISTICS
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. 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. 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. 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. 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 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