GLUTAROL™ 10% w/v CUTANEOUS SOLUTION

Glutaraldehyde 10.0% w/v.

Colourless, evaporative cutaneous solution.

For the topical treatment of warts, especially plantar warts.

For adults, children and the elderly:

1. Gently rub the surface of the wart with a piece of pumice stone or manicure emery board, or pare down any hard skin.

2. Using the applicator provided, carefully apply a few drops of the paint to the wart, taking care to localise the application to the affected area. Allow each drop to dry before the next is applied.

3. Repeat twice daily.

4. On subsequent days, repeat steps 1 to 3. It is not necessary to cover the treated wart(s) with an adhesive plaster.

Not to be used in cases of sensitivity to any of the ingredients. Not to be used on the face, anal or perineal region. Not to be used on moles or on any other skin lesion for which it is not indicated.

Keep away from the eyes and mucous membranes. Avoid spreading onto surrounding uninvolved skin. Avoid spillage. Avoid inhaling vapour. Replace cap tightly after use. For external use only.

None known.

No special precautions.

None known.

Undesirable effects occur very occasionally and mostly involve mild local skin rashes and irritation. Very rarely, a severe reaction may occur particularly on the hands or when the product is used excessively and allowed to spread onto surrounding normal skin. If mild irritation should occur, apply a reduced amount (taking special care to avoid spreading beyond the wart or verruca) and apply less often. If the irritation is severe, patients should stop treatment immediately and seek medical advice.

Accidental oral ingestion should be treated immediately by gastric lavage with 2 to 5% aqueous sodium bicarbonate solution. Fluid and electrolyte balance should be monitored and appropriate supportive measures should be provided. Symptoms include headache, nausea, vomiting, diarrhoea and respiratory depression.

Glutaraldehyde is virucidal and thus inactivates the wart virus. On the skin, it also acts as an anhidrotic, drying the warts and surrounding skin, thus reducing the spread of lesions and simplifying the removal of persistent warts by curettage.

As glutaraldehyde stains the outer layer of the skin brown, treatment can be seen to be carried out. This stain soon disappears after cessation of treatment.

Addition of ethanol to the formulation stabilises the glutaraldehyde against irreversible polymerisation during storage but at the same time diminishes its activity. However, when the aqueous ethanolic solution is applied to the skin, the alcohol rapidly evaporates leaving a concentrated aqueous solution of glutaraldehyde which is highly reactive and attacks the wart before it has time to polymerise. Thus, the ethanolic formulation is stable in storage, as confirmed by stability tests, but is immediately activated when applied to the skin and the alcohol is allowed to evaporate.

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

IMS; Purified Water.

None known.

36 months.

Flammable. Keep away from flames. Keep upright. Do not store above 25°C.

10 ml amber glass bottle with plastic screw cap, incorporating a specially designed spatula for ease of application.

Not applicable.

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

00173/0022.

15 September 2005.

June 2011.