Dermax Therapeutic Shampoo

1. Name Of The Medicinal Product

DERMAX™ THERAPEUTIC SHAMPOO

2. Qualitative And Quantitative Composition

Benzalkonium Chloride 0.5% w/w

3. Pharmaceutical Form

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 Warnings 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.

4.9 Overdose

There are no known toxic effects resulting from excessive use of Dermax Therapeutic 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 sulphate, 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 Dermax Therapeutic 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 Sulphate; 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.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep bottle in outer carton.

6.5 Nature And Contents Of Container

250 ml white high density polyethylene bottle with a polypropylene dispensing screw cap. This is supplied as an original pack (OP).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts, SG4 7QR, UK.

8. Marketing Authorisation Number(S)

00173/0198.

9. Date Of First Authorisation/Renewal Of The Authorisation

20 November 2009.

10. Date Of Revision Of The Text

July 2006.