Hedrin® 4% cutaneous solution

Packaging to state: Hedrin 4% lotion dimeticone

Dimeticone 4% w/w

For a full list of excipients, see section 6.1.

Cutaneous solution.

Hedrin is a clear, colourless liquid.

Hedrin is indicated for the eradication of headlice infestations.

Adults and children (aged six months and above)

For topical external use only.

Apply sufficient lotion to cover dry hair from the base to the tip to ensure that no part of the scalp is left uncovered. Work into the hair spreading the liquid evenly from roots to tips. Allow hair to dry naturally. Hedrin should be left on hair for a minimum of 8 hours or overnight. Wash out with normal shampoo, rinsing thoroughly with water. Repeat the treatment after seven days.

Children under the age of six months should only be treated under medical supervision.

Hypersensitivity to any of the ingredients.

Discontinue at the first appearance of a skin rash or any other signs of local or general hypersensitivity.

For external use only.

If accidentally introduced into the eyes, flush with water.

Consult a pharmacist if live lice are detected after the second treatment or if head lice are a persistent or recurring problem.

Dimeticone is not known to interact with other drugs.

There is no data to suggest that Hedrin may not be used in pregnancy.

None known.

Dimeticone is usually well tolerated. Minor adverse events include an itchy or flaky scalp and dripping/irritation around the eyes.

There are no known recognised symptoms of overdose.

It is unlikely that Hedrin® lotion will enter the bloodstream via scratched skin however if this does occur, available data suggests it will be rapidly eliminated unchanged. If the lotion were to be accidentally ingested, again, the available data suggests that there are no specific safety concerns.

No special procedures are likely to be needed.

ATC Code: PO3 AX Other entoparasiticides, incl Scabicides

The solution contains dimeticone, which is used in many pharmaceutical and cosmetic preparations. A 4% concentration has been found to affect the physico-physiological activity of lice. It is less effective in its ovicidal activity and therefore two applications 7 days apart are required.

Hedrin contains no neurotoxic organophosphate insecticides and therefore does not work by acting on specific enzymes within the louse. The Hedrin solution acts on the lice by a physical process to cover the lice and disrupt the ability of the lice to manage its water balance so that treated insects fail to excrete surplus water. Hedrin activity is not diminished in insecticide resistant head lice.

Hedrin is applied topically to the affected area but there is little or no absorption of Hedrin through the skin.

There are no further relevant data.

Cyclomethicone 5.

None known.

Three years, when stored unopened.

This product does not require any special storage conditions.

HDPE dropper containers with screw caps; 50ml & 100ml capacity.

HDPE containers incorporating plastic trigger spray, cap and PE dip tube; 60ml & 100ml capacity.

Not all packs may be marketed.

Care should be taken as the product may cause a slip hazard if accidentally spilt onto smooth surfaces.

Thornton & Ross Ltd

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

PL 00240/0137

23/11/2005, 15/06/2010

23/11/2005 / 24/08/2006 / 24/06/08/15/06/2010

Not applicable

Not applicable