Dermax Therapeutic Shampoo
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dermax Therapeutic Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzalkonium Chloride 0.5% w/w
3 PHARMACEUTICAL FORM
Shampoo
Clear, pale yellow to straw coloured viscous shampoo.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the topical treatment of pityriasis capitis and other seborrhoeic scalp conditions, where there is scaling and dandruff.
4.2. Posology and method of administration
For adults, children and the elderly.
Wet the hair. Apply a liberal quantity of the shampoo to the scalp and, with the tips of the fingers, rub in thoroughly. Rinse. Repeat the application and massage to produce a rich lather. Remove as much lather as possible with the hands, before rinsing thoroughly under running water.
4.3. Contraindications
Not to be used in cases of sensitivity to any of the ingredients.
4.4.
Special warning and precautions for use
Keep away from the eyes.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
No special precautions.
4.7. Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
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
There are no known toxic effects resulting from excessive use of Dermol Shampoo.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The surface active cationic germicide, benzalkonium chloride, is adsorbed on to dry skin scales, which are a feature of pityriasis capitis and other seborrhoeic scalp conditions. The scales are thereby loosened and attain a net positive charge. In the presence of the anionic foaming agent, sodium lauryl ether sulfate, the dandruff scales are then levitated into the negatively charged surface of the foam, and are thus washed from the hair.
The benzalkonium chloride also acts as a mild antiseptic which improves clinical performance where the condition is exacerbated by the presence of microbes.
The major site of action against micro-organisms appears to be the cell membrane, where permeability is altered.
5.2. Pharmacokinetic properties
The effect of Dermol Shampoo is entirely superficial since it acts on the outer surface of the stratum corneum, treating the external manifestations of the recommended clinical indications. For this reason, no pharmacokinetic studies have been undertaken.
5.3 Preclinical safety data
No relevant information additional to that included elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium lauryl ether sulfate Coconut diethanolamide Dilute hydrochloric acid Phenoxyethanol Sodium chloride
Lauryldimonium hydroxypropyl hydrolyzed collagen Coconut oil Purified water
6.2 Incompatibilities
None known.
6.3. Shelf life
36 months in unopened container.
6.4. Special precautions for storage
Do not store above 25 °C.
Keep bottle in outer carton.
6.5. Nature and contents of container
100 or 250 ml white high density polyethylene bottle with a polypropylene dispensing screw cap.
25 or 30 ml white high density polyethylene bottle with a polypropylene screw cap.
These are supplied as original packs.
6.6. Instructions for use and handling
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Diomed Developments Limited T/A Dermal Laboratories Tatmore Place,
Gosmore
Hitchin,
Herts,
SG4 7QR,
UK
8. MARKETING AUTHORISATION NUMBER
PL 00173/0198
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/11/2009
10 DATE OF REVISION OF THE TEXT
14/05/2015