Summary of Product Characteristics Updated 22-May-2018 | Pinewood Healthcare
Hydrocortisone 1% w/w Cream
Derma Care 1% w/w Cream
Each 1 gram of the cream contains 10 mg of hydrocortisone (i.e. 1 %w/w).
Excipients with known effect
Each 1 gram of the cream contains 1 mg of chlorocresol (i.e. 0.1 %w/w) and 90 mg of cetomacrogol emulsifying wax (which contains cetostearyl).
For the full list of excipients, see section 6.1.
Cream for cutaneous use only.
Hydrocortisone has topical anti-inflammatory activity of value in the treatment of irritant dermatitis, contact allergic dermatitis, insect bite reactions and mild to moderate eczema.
Use sparingly over a small area once/twice a day for a maximum period of one week. 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 advice.
Method of administration
For cutaneous use.
Bacterial (e.g. impetigo), viral (e.g. Herpes simplex) or fungal (e.g. candidal or dermatophyte) infections of the skin.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Use on the eyes and face, Ano-genital region, Broken or infected skin including cold sores, acne and athlete's foot.
Remarks on indications
1. There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions or short-lived weal and flare reactions from other causes.
2. Topical corticosteroids are ineffective in granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis.
3. Topical corticosteroids are not generally indicated in psoriasis excluding widespread plaque psoriasis provided that warnings are given.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis, and local and systematic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.
Although generally regarded as safe, even for long-term administration in adults, there is potential for overdosage in infants and children. Extreme caution is required in dermatoses of infancy especially napkin eruption where the napkin can act as an occlusive dressing and increase absorption. In infants and children, courses of treatment should therefore not normally exceed 7 days.
Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions, which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and a systemic administration of antimicrobial agents.
As with all corticosteroids, prolonged application to the face is undesirable.
Do not use under an occlusive dressing.
This medicinal product contains chlorocresol, which may cause allergic reactions.
This medicinal product also contains cetostearyl alcohol in the excipient cetomacrogol emulsifying wax, and may cause local skin reactions (e.g., contact dermatitis).
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.
There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Cream is administered to nursing mothers. In this event, the product should not be applied to the chest area.
Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Pharmacotherapeutic group: Corticosteroids, weak (group I); ATC code: D07A A02
Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in 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 granules 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 metabolised 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 as glucuronides. Only very small amounts of unchanged hydrocortisone are excreted.
Adverse effects of Hydrocortisone are due to its effects on electrolyte balance, metabolism and particularly adrenal suppression. Topical use of Hydrocortisone has only rarely been associated with systemic side effects.
Cetomacrogol Emulsifying Wax
White Soft Paraffin
Do not store above 25°C.
A collapsible aluminium 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: 15g.
Not all pack sizes may be marketed.
Any unused medicinal products or waste material should be disposed of in accordance with local requirements.
Pinewood Laboratories Limited,
Trading as Pinewood Healthcare,
11/11/1997 / 01/08/2003
Ballymacarby, Clonmel, Co. Tipperary, Co. Tipperary, Ireland
+353 52 6186000
+44 1978 661 261
+44 1978 661 702
+ 353 52 6136311