Capasal Therapeutic Shampoo

1. Name Of The Medicinal Product

CAPASAL™ THERAPEUTIC SHAMPOO

2. Qualitative And Quantitative Composition

Salicylic Acid 0.5% w/w; Coconut Oil 1.0% w/w; Distilled Coal Tar 1.0% w/w.

3. Pharmaceutical Form

Viscous, golden brown shampoo.

4. Clinical Particulars

4.1 Therapeutic Indications

For use as a shampoo in the treatment of dry, scaly scalp conditions such as seborrhoeic eczema, seborrhoeic dermatitis, pityriasis capitis, psoriasis, and cradle cap in children. It may also be used to remove previous scalp applications.

4.2 Posology And Method Of Administration

For adults, children and the elderly: Use as a shampoo, daily if necessary. Wet the hair thoroughly. Massage a small amount of the shampoo into the scalp, leaving on for a few minutes before washing out. Repeat, producing a rich lather. Rinse hair well and dry.

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. Keep out of the reach of children. For external use only. In case of irritation, discontinue treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No known side-effects.

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 Capasal.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The preparation has been designed as an aid in the treatment of dry, scaly scalp conditions by incorporating into a shampoo formulation three well known ingredients which have been established as safe and effective for use in this indication. They are as follows:

0.5% salicylic acid - mild keratolytic

1.0% coconut oil - emollient, softening agent and lubricant

1.0% distilled coal tar - anti-pruritic, keratoplastic

The preparation may also be used conveniently to remove any previous topical application.

5.2 Pharmacokinetic Properties

The active ingredients of the formulation are readily available for intimate contact with the skin, as the shampoo is massaged into the scalp and left on for a few minutes before washing out. This is then repeated in order to produce a rich lather. The detergent effect of the shampoo will also remove any previous application to the scalp.

5.3 Preclinical Safety Data

No relevant information additional to that contained elsewhere in the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lauric Acid Diethanolamide; Coco Amido Propyl Dimethyl Betaine; Triethanolamine Lauryl Sulphate (trolamine lauril sulfate); Phenoxyethanol; Ammonium Sulphate; 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 away from direct sunlight.

6.5 Nature And Contents Of Container

Plastic 'flip top' bottle containing 250 ml. 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)

00173/0048.

9. Date Of First Authorisation/Renewal Of The Authorisation

29 January 2006.

10. Date Of Revision Of The Text

August 2011.