Pinewood's Bites and Stings

Pinewood's Bites and Stings Relief Cream

Sainsbury's Healthcare Bites and Stings Relief 1% w/w Cream

Morrison's Bites and Stings Relief 1% w/w Cream

Numark Bites and Stings Relief 1% w/w Cream

Hydrocortisone 1% w/w

For excipients, see 6.1

Cream Hydrocortisone 1% Cream is a smooth white cream.

Hydrocortisone has topical anti-inflammatory activity of value in the treatment of insect bite and sting reactions.

For cutaneous use.

Adults and children aged 10 years and over:

Use sparingly over a small area once or twice a day for a maximum period of 2-3 days. If the condition has not improved, or worsens, consult your doctor. This product should not be recommended for use on children under 10 years of age without medical supervision.

Bacterial (e.g. impetigo), viral (e.g. Herpes simplex) or fungal (e.g. candidal or dermatophyte) infections of the skin.Hypersensitivity to any of the ingredients.Use on the eyes and face, ano-genital region, broken or infected skin including cold sores, acne and athletes foot.

The label will state:Contains hydrocortisone. Do not use on the eyes, face or ano-genital region, broken or infected skin including scabies and infected bites and strings. Do not use in pregnancy without medical advice.Do not use on children under 10.Stop treatment if symptoms of hypersensitivity occur.If the condition does not improve after 2-3 days consult a doctor.Not to be used for other bites or stings or for other skin conditions.Chlorocresol may cause allergic reactions.Cetomacrogol emulsifying wax contains cetosterly alcohol which may cause local skin reaction (e.g. contact dermatitis)

None known.

This product should not be used in pregnancy without medical advice. There is no information about effects on lactation.

None known.

Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should be stopped immediately.Striae may occur especially in intertriginous areas.Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Not applicable.

ATC Code: D07A A02. Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction on the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates. The granulation reaction is also decreased due to the inhibition effect of Hydrocortisone on connective tissue. Stabilisation of most cell graduates and lysomal membranes decreases the mediators involved in inflammatory response and reduces release of enzymes in prostaglandin synthesis. The vasoconstrictor action of Hydrocortisone may also contribute to its anti-inflammatory activity.

Absorption: Topically applied steroids are absorbed to a significant extent only if applied to broken skin, to very large areas, or under occlusive dressings.Distribution: Corticosteroids are rapidly distributed to all body tissues. They cross the placenta and may be excreted in small amounts in breast milk.Metabolism: Hydrocortisone is metabolized mainly in the liver but also the kidney, to various degraded and hydrogenated forms such as tetrahydrocortisone.Elimination: Hydrocortisone is excreted in the urine, mostly conjugated glucuronides. Only very small amounts of unchanged hydrocortisone are excreted.

Adverse effects of Hydrocortisone are due to its effect on electrolyte balance, metabolism and particularly adrenal suppression. Topical use of Hydrocortisone has only rarely been associated with systemic side effects.

Cetomacrogol Emulsifying WaxChlorocresolLiquid ParaffinMacrogol 300White Soft ParaffinPurified Water

None known.

60 months.

Do not store above 25°C.

A collapsible aluminum tube, with a membrane seal at the nozzle, internal epoxy lacquer, latex end seal band in the crimp seal and a white plastic cap for reclosure after piercing membrane.Pack Size: 10g.

No special precautions required.

Pinewood Laboratories LimitedTrading as Pinewood Healthcare Ballymacarbry Clonmel Co Tipperary Ireland

PL 04917/0062

11^th December 2003

14/12/2015