DICLOR Solution for topical application Ref.[27599] Active ingredients: Aluminium chloride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited <u>trading as:</u> Stiefel, 980 Great West Road, Brentford, Middlesex, TW8 9GS,United Kingdom

4.1. Therapeutic indications

Driclor is indicated for the treatment of hyperhidrosis of the armpits (axillae), the hands and the feet.

4.2. Posology and method of administration

Driclor is for application to the axillae, palms of the hands or soles of the feet.

Before applying aluminium chloride hexahydrate, the affected area should be dried thoroughly to avoid burning of the skin (see Warnings and Precautions).

Apply Driclor last thing at night after drying the affected areas carefully. Wash off in the morning. Do not re-apply the product during the day.

Initially the product may be applied each night until sweating stops during the day. The frequency of application may then be reduced to twice a week or less.

4.9. Overdose

Symptoms and signs

Application more frequently than recommended may increase the severity of skin irritation.

Ingestion can cause nausea, vomiting, diarrhoea and burning in the mouth and throat.

The formulation contains a significant quantity of ethanol. Systemic absorption of this should be considered a possibility in the event of overdosage.

Treatment

In the event of accidental oral ingestion rinse the mouth with plenty of water.

Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

6.3. Shelf life

For the product as packaged for sale: 3 years.

After first opening the container: Comply with expiry date.

6.4. Special precautions for storage

Store in a cool place below 25°C. Keep away from naked flame. Store upright.

6.5. Nature and contents of container

High density polyethylene bottle with roll-on applicator.

Pack size: 30ml, 40ml, 45ml, 50ml and 60ml

High density polyethylene bottle with polypropylene cap.

LDPE housing containing polypropylene roller-ball with over-cap for self-assembly.

Pack Size: 60ml, 75ml

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

The pack should be assembled according to the instructions in the package leaflet.

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