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Dermax Therapeutic Shampoo

Active Ingredient:
benzalkonium chloride
Dermal Laboratories Limited See contact details
ATC code: 
About Medicine
{healthcare_pro_orange} This information is for use by healthcare professionals
Last updated on emc: 12 Mar 2024
1. Name of the medicinal product

Dermax Therapeutic Shampoo

Dermol Shampoo

2. Qualitative and quantitative composition

Benzalkonium Chloride 0.5% w/w

Excipients with known effect:

Sodium benzoate (E 211)

For the full list of excipients, see section 6.1.

3. Pharmaceutical form


Clear, colourless to pale yellow 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.

Use as a shampoo, daily if necessary, reducing the frequency of use to once or twice a week as the condition improves. Thereafter, occasional use may be necessary. Wet the hair. Apply a sufficient quantity of the shampoo to the scalp to produce a rich lather (approximately a quantity the size of a fifty pence piece for short hair, adjusting up depending on length/thickness of hair) and, with the tips of the fingers, rub in thoroughly. Rinse. If necessary, 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 hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Keep away from the eyes.

In case of irritation, or if there is no improvement after 4 weeks, or the scalp condition seems to look or feel worse, discontinue treatment and tell your doctor, pharmacist or nurse.

This medicine contains 5mg of sodium benzoate (E 211) per gram of shampoo. Sodium benzoate (E 211) may cause local irritation. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, 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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

There are no known toxic effects resulting from excessive use of the shampoo.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Medicated Shampoos. ATC code: D11AC.

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 the 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

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

6. Pharmaceutical particulars
6.1 List of excipients

Coconut oil

Dilute hydrochloric acid

Lauryldimonium hydroxypropyl hydrolysed collagen (contains phenoxyethanol and potassium sorbate)

Macrogol lauryl ether (4)

Sodium benzoate (E 211)

Sodium chloride

Sodium lauryl ether sulfate (contains sodium hydroxide as a pH adjuster)

Purified water

6.2 Incompatibilities

Not applicable.

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.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Diomed Developments Limited

T/A Dermal Laboratories

Tatmore Place






8. Marketing authorisation number(s)

PL 00173/0198

9. Date of first authorisation/renewal of the authorisation

18 May 2005 / 17 May 2010 (unlimited validity)

10. Date of revision of the text


Dermal Laboratories Limited
Company image
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 458 866