Dermal Laboratories Limited

CAPASAL™ THERAPEUTIC SHAMPOO

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

Golden brown foaming shampoo.

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.

For adults, children and the elderly. After thoroughly wetting the hair, massage a small amount of shampoo into the scalp and leave for a few minutes before washing out. Repeat, giving a thick lather. Rinse the hair well and dry.

Not to be used in cases of sensitivity to any of the ingredients.

Protect the eyes from the shampoo. Keep out of the reach of children. If there is no improvement or the condition is aggravated, consult the doctor. For external use only.

None known.

There is inadequate evidence of safety in pregnant and lactating women but coal tar preparations have been in use for many years without apparent ill-consequence and no harmful effects on the health of the child is anticipated with the proper use of this product. However, it is recommended that the use of coal tar in pregnancy and lactation be restricted to intermittent use, in a low concentration on a relatively small percentage of body surface and that use during the first trimester be avoided.

None known.

Although carcinogenicity of coal tar has been demonstrated in animal studies, no studies demonstrating an increased risk of skin cancer with normal therapeutic use in humans have been reported. There is no unequivocal evidence to link the use of topically applied coal tar products with skin cancer (see also Section 5.3).

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

The preparation has been designed as an aid in the treatment of dry, scaly scalp conditions by incorporating into a convenient shampoo formulation three well known ingredients which have been established as safe and effective, for example in Coconut Oil Compound Ointment (Ung Cocois Co), for use in these indications. 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.

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 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.

Tar preparations have been in wide use for many years. Although coal tar preparations containing polycyclic aromatic hydrocarbons have been demonstrated to be carcinogenic in the skin of experimental animals, present evidence based upon epidemiology studies in humans and follow-up trials, reveals no evidence of increased risk of skin or internal cancer, particularly when the product is used as directed.

Lauric Acid Diethanolamide; Coco Amido Propyl Dimethyl Betaine Solution; Triethanolamine Lauryl Sulphate Solution; Ammonium Sulphate; Phenoxyethanol; Water.

None known.

36 months.

Do not store above 25°C.

Plastic 'flip top' bottles containing 100 ml and 250 ml. These are supplied as original packs (OP).

No special requirements.

Dermal Laboratories Limited

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK

PA 278/16/1.

10 January 2006.

August 2011.