Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Hydrocortisone ointment 1% (POM)

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Hydrocortisone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Hydrocortisone

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

FOR Hydrocortisone ointment contains the active substance micronised hydrocortisone. Hydrocortisone belongs to a group of medicines called corticosteroids, which act to relieve pain and swelling. Hydrocortisone ointment is a topical anti-inflammatory used in the treatment of:

  • eczema
  • dermatitis, including intertrigo (irritation between skin folds)
  • insect bite reactions
  • inflammation of the external ear (otitis externa)
  • prurigo nodularis – a long term skin condition where very itchy lumps appear
  • neurodermatoses – a long term skin condition where itchy skin becomes thick due to scratching
  • nappy rash, if the infection is being treated by antibiotics.

What you need to know before you take it

E HYDROCORTISONE OINTMENT Hydrocortisone 1% is classed as a mild corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition. Do not use Hydrocortisone ointment:

  • If you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6)
  • If you have an untreated skin infection such as athlete's foot (tinea pedis), chickenpox (varicella) or shingles (Herpes zoster), coldsores (Herpes simplex), impetigo, ringworm or thrush, infected lesions, ulcerative conditions, red appearance on face, peri-oral dermatitis or acne. Warnings and precautions Talk to your doctor or pharmacist before using Hydrocortisone ointment:
  • If you have psoriasis; the condition may become worse after stopping long-term treatment
  • If you will be applying the ointment to your face. This ointment should not be used for long on the face as it may damage the facial skin
  • If you will be using the ointment for the treatment of dermatitis or nappy rash on children and infants. In this case the courses of treatment should not normally exceed 7 days
  • If you are using this ointment under occlusive dressing that can considerably increase absorption of this ointment.
  • If there is a worsening of your condition during use consult your prescriber – you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment.
  • If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using the cream/ointment without consulting your prescriber unless your prescriber has previously advised you to so.
  • If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment. Caution should be taken to keep away from the eyes. Contact your doctor if you experience blurred vision or other visual disturbances. Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing. bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. Children Treatment in children should be restricted to no more than 5-7 days. Other medicines and Hydrocortisone ointment Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you are breastfeeding, do not apply the product to your chest area. Hydrocortisone Ointment contains wool fat (lanolin) This may cause local skin reactions (e.g. contact dermatitis).

How to take it

HYDROCORTISONE OINTMENT Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Wash your hands before and after applying Hydrocortisone ointment, but if applying to the hands, do not wash after application.

  • Apply a small amount of ointment and smooth over the affected area
  • If the affected area becomes weepy or infected, stop using the ointment and speak to your

Front Side

Dimensions – 150 x 300 mm

doctor. You may need to start antibiotic treatment, especially if the infection spreads

  • You should not normally use Hydrocortisone ointment on the face for many weeks or months, unless specifically prescribed by your doctor. The recommended dose is: Adults (including the elderly)
  • Gently apply ointment to the affected area(s) two or three times a day, reducing as the skin heals. Children and Infants
  • Apply as for adults but avoid long term use. Treatment should be limited to seven days – especially in infants
  • The lowest concentration suitable should be used
  • Do not use under a nappy or an airtight dressing (such as a plaster) on an infant because this will enable too much active ingredient to pass through the skin. Follow your doctor's instructions carefully if using to treat nappy rash. If you use more Hydrocortisone ointment than you should If you have squeezed out too much ointment, wipe off the excess with a paper towel. Do not use the ointment under dressings (such as plasters) or nappies because too much hydrocortisone may be absorbed and may result in adverse effects upon adrenal gland function. If you forget to use Hydrocortisone ointment If you forget to apply the Hydrocortisone ointment, apply it as soon as possible and carry on as before. If it is 3 hours or less until the next application, then ignore the missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. Most patients using Hydrocortisone ointment will have no problems when used in the correct amount for the prescribed time. If the following happens, stop using the ointment and tell your doctor immediately or go to the casualty department at your nearest hospital:
  • an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives). This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. Other effects which may occur:
  • The skin may become thinner when used in the nappy areas of children where conditions are moist
  • If Hydrocortisone ointment is used often and for a long time, especially under dressings, adverse effects on adrenal gland function are more likely. These effects are also more likely in children and infants
  • Prolonged use, especially on sensitive areas including skin folds, may result in thinning of the skin, widening of the blood vessels, stretch marks and may suppress the functioning of the adrenal gland
  • Blurred vision. This side effect has been reported, but the frequency for it to occur is not known.
  • Steroid withdrawal reaction: If used over prolonged periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment, with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores. If your condition becomes worse during treatment you may have an allergy to one of the ingredients or an infection. Stop using the ointment and tell your doctor as soon as possible. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

Possible side effects

not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

HYDROCORTISONE OINTMENT Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not store above 25 °C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Hydrocortisone ointment contains The active substance is micronised hydrocortisone. The other ingredients are Wool fat (see section 2), liquid paraffin and white soft paraffin. What Hydrocortisone ointment looks like and contents of the pack A collapsible aluminium tube, with a membrane seal at the nozzle, internal epoxy lacquer, latex endseal band in the crimp seal areaand a white plastic cap for reclosure after piercing membrane. Hydrocortisone ointment is provided in 10g, 15g, 30g & 50g tubes. Not all pack sizes may be marketed. Manufacturer Marketing Authorisation Holder Beltapharm SpA Strides Pharma UK Ltd., Via Stelvio, 66 – 20095 Cusano Unit 4, The Metro Centre Milanino – Milan – Italy Dwight Road, Watford, WD18 9SS United Kingdom This leaflet was last revised in 12/2023.

PL 13606/0186 1049421

PATIENT INFORMATION LEAFLET HYDROCORTISONE OINTMENT 1%

Back side

Dimensions – 150 x 300 mm

Hydrocortisone Ointment 1% (Beltapharma) SPUK

Pack Insert

150 x 300 mm 1049421

–1047883

Black

PC-TSG/2023/150 – Record Number:395052 / PC-TSG/2023/169 – Record Number:397879 Front & Back Printing. To be supplied in folded size of 150 x 150mm 40 GSM Bible Paper Printing clarity to be clear & sharp. NA

1 2.0

Frequently asked questions about Hydrocortisone ointment 1% (POM)

How do I take Hydrocortisone ointment 1% (POM)?

Hydrocortisone ointment 1% (POM) comes as ointment. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Hydrocortisone ointment 1% (POM)?

The active substance in Hydrocortisone ointment 1% (POM) is hydrocortisone.

Are there equivalent medicines to Hydrocortisone ointment 1% (POM)?

Medicines with the same active substance, strength and form include: Boots DermaCare Hydrocortisone 1% w/w Ointment, Hydrocortisone 0.5% Ointment / Efcortelan Ointment 0.5%, Hydrocortisone 1% Ointment / Efcortelan Ointment 1.0%. In total there are 8 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Hydrocortisone ointment 1% (POM), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Hydrocortisone ointment 1% (POM) without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Hydrocortisone (42 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Hydrocortisone has topical anti-inflammatory activity of value in the treatment of a wide variety of dermatological conditions, including the following:

• eczema – atopic, infantile, discoid, stasis

• dermatitis - primary irritant, contact allergic, photo or seborrheic

• prurigo nodularis

• neurodermatoses

• otitis externa

• intertrigo

• insect bite reactions

• napkin rash, where concurrent infection is excluded or being addressed.

4.2. Posology and method of administration

Posology

Adults and elderly: Apply, once to four times daily gradually increasing the intervals between applications as the condition improves. Treatment may then be reduced to two to three times a week or when symptoms recur. Gentle massage assists penetration. The same dose is used for adults and the elderly, as clinical evidence would indicate that no special dosage regimen is necessary in the elderly.

Children and infants: Gently apply a thin layer of ointment to the affected area(s) two or three times a day. Long term therapy should be avoided and where possible limited to five to seven days.

Method of administration

For cutaneous use only.

4.3. Contraindications

• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

• Use on untreated bacterial (e.g. impetigo), fungal (e.g. candida or dermatophyte) or viral (e.g. herpes simplex) infections of the skin, infected lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne.

4.4. Special warnings and precautions for use

The label will state mild steroid.

Visual disturbance:

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

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.

In infants and children, long-term treatment should be avoided especially on the face as adrenal suppression can occur.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development tolerance, the risk of generalised pustular psoriasis and local and systemic 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 adverse effects if overused in infancy. Extreme caution is required in dermatoses of infancy, including napkin eruption. In such patients, courses of treatment should not normally exceed seven days.

Appropriate antimicrobial therapy should be used treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.

Topical steroid withdrawal syndrome

Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.

In infants and children particularly, care should be taken that the lowest strength of hydrocortisone ointment that is clinically effective is used. The 2.5% strength is normally only necessary in the more severe cases and is better avoided in infants.

The use of an occlusive dressing can considerably increase the degree of systemic absorption.

As with all corticosteroids, application to the face may damage the skin and should be avoided. Caution should be taken to keep away from the eyes.

Healthcare professionals should be aware that if the product comes into contact with dressing, clothing and bedding, the fabric can be easily ignited with a naked flame.

Patients should be warned of this risk and advised to keep away from fire when using this product.

4.5. Interaction with other medicinal products and other forms of interaction

None known

4.6. Fertility, pregnancy and lactation

Pregnancy

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. Therefore there be a small risk of such events in the human foetus. There is a theoretical risk of such effects on the human foetus.

Breast-feeding

There is no evidence against use in lactating women. However, caution should be exercised when hydrocortisone ointment is administered to nursing mothers. In this event, the product should not be applied to the chest area. There is theoretical risk of infant adrenal function impairment if maternal systemic absorption occurs.

4.7. Effects on ability to drive and use machines

None known

4.8. Undesirable effects

Treatment with hydrocortisone ointment is usually well tolerated but treatment should be stopped immediately if symptoms of hypersensitivity occur.

Epidermal thinning, telangiectasia and striae may occur in areas of high absorption such as skin folds, the face and where occlusive dressings are used. Local atrophic changes may occur in intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption.

Following prolonged topical use systemic absorption from sites may be sufficient to produce hypercorticism and suppression of the pituitary adrenal axis after prolonged treatment. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin are treated.

Eye disorders:

Frequency not known: Vision, blurred (see section 4.4).

Skin and Subcutaneous Tissue Disorders

Not known (cannot be estimated from available data) Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see section 4.4).

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.

4.9. Overdose

Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically. Acute overdosage is very unlikely to occur. In the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation, topical steroids should be discontinued.

💬 Ask about this leaflet

Ask anything about Hydrocortisone ointment 1% (POM). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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