DERBAC M Cutaneous emulsion Ref.[49891] Active ingredients: Malathion

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: LanesHealth (Ireland) Limited, Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, Ireland

4.1. Therapeutic indications

  • For the treatment of severe infestation of the scalp or pubic with lice (T. Pediculosis).
  • For the treatment of scabies

4.2. Posology and method of administration

For topical external use only.

Adults, the elderly and children aged 6 months and over

As this product does not contain alcohol, it may be more suitable for those with asthma or eczema.

Treatment of head lice

Rub the liquid into the scalp until all the hair and scalp is thoroughly moistened. Leave the hair to dry naturally in a warm but well ventilated room. After 12 hours, or the next day if preferred, shampoo the hair in the normal way.

Rinse the hair and comb whilst wet to remove dead lice and eggs (nits) using the Nit Comb.

Treatment should be repeated after 7 days.

Treatment of crab (pubic) lice

Apply Derbac-M Liquid to the entire skin surface. Pay particular attention to all hairy areas including beards and moustaches. Avoid any other areas above the neck. Leave on for at least one hour before washing but preferably Derbac-M Liquid should be left on overnight. Wash off in the usual manner.

Treatment should be repeated after 7 days.

Treatment of scabies

Apply Derbac-M Liquid to the entire skin surface. In adults it may not be necessary to apply above the neck but children under the age of two years should have a thin film of Derbac-M Liquid applied to the scalp, face and ears, avoiding the eyes and mouth.

Do not wash off or bathe for 24 hours. If hands or any other parts must be washed during this period, the treatment must be reapplied to those areas immediately.

Treatment should be repeated after 7 days.

No special sterilisation of clothing is necessary, ordinary laundering or dry-cleaning with hot-iron pressing are sufficient.

The infestation is cleared by the treatment. However, the itching and rash may persist for up to 7 days. An anti-irritant cream can be applied if necessary.

Family members and close contacts should also be treated simultaneously.

Children aged 6 months and under

Under medical supervision only.

4.9. Overdose

It is most unlikely that a toxic dose of Malathion will be ingested. Treatment consists of gastric lavage, assisted respiration and, if necessary in the event of massive ingestion, administration of atropine together with pralidoxime.

6.3. Shelf life

Two and a half years.

6.4. Special precautions for storage

Do not store above 25°C. Store the bottle in the outer carton in order to protect from light.

6.5. Nature and contents of container

Cartoned, clear or amber glass (Ph. Eur. Type III) bottles with polyethylene caps with an HDPE body, HDPE ring and a polyethylene LDPE plug containing either 50, 55, 150, 160, 200 or 210 ml of product. Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product.

6.6. Special precautions for disposal and other handling

No special requirements.

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