- hydrocortisone butyrate
POM: Prescription only medicine
This information is intended for use by health professionals
Locoid Crelo contains 0.1% w/w hydrocortisone butyrate.
Excipient(s) with known effect:
Cetostearyl alcohol (2% w/w)
Butylhydroxytoluene (0.02% w/w)
Propylene glycol (5% w/w)
Propyl parahydroxybenzoate (0.3% w/w)
Butyl parahydroxybenzoate (0.15% w/w)
For the full list of excipients, see section 6.1
The product is a white emulsion.
Locoid Crelo is indicated in adults, children and infants. The product is recommended for clinical use in the treatment of conditions responsive to topical corticosteroids, e.g. eczema, dermatitis and psoriasis. The product is intended for topical application especially to the scalp or hirsute skin.
Topical corticosteroids are not generally indicated in psoriasis but may be acceptable in psoriasis excluding widespread plaque psoriasis provided warnings are given, see section 4.4 Special warnings and precautions for use.
Adults and older people
The same dose is used for adults and older people, as clinical evidence would indicate that no special dosage regimen is necessary in older people.
Long term treatment should be avoided where possible.
Therapy should be limited if possible to a maximum of seven days.
Method of administration
For cutaneous use.
Dosage: To be applied evenly and sparingly no more than twice daily.
The formulation of the product makes it suitable for use in both scaly lesions and for moist, weeping lesions.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
This preparation is contraindicated in the presence of untreated viral or fungal infections, tubercular or syphilitic lesions, peri-oral dermatitis, acne vulgaris and rosacea and in bacterial infections unless used in connection with appropriate chemotherapy.
As with all corticosteroids, application to the face, flexures and other areas of thin skin may cause skin atrophy and increased absorption and should be avoided.
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 systemic toxicity due to impaired barrier function of the skin. Steroids may have a place in psoriasis of the scalp and chronic plaque psoriasis of the hands and feet. Careful patient supervision is important.
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.
The cetostearyl alcohol and butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis). The propylene glycol may cause skin irritation. The butylhydroxytoluene may cause irritation to the eyes and mucous membranes (e.g. nose). The propyl and butyl parahydroxybenzoate may cause allergic reactions which can be delayed.
Instruct patients not to 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.
Although generally regarded as safe, even for long-term administration in adults, there is a potential for adverse effects if over used in infancy. Extreme caution is required in dermatoses of infancy including napkin eruption. In such patients, courses of treatment should not normally exceed 7 days.
Keep away from the eyes.
No interaction studies have been performed.
There are no or limited amount of data from the use of hydrocortisone butyrate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Hydrocortisone butyrate/metabolites are excreted in human milk, but at therapeutic doses of Locoid Crelo no effects on the breast-fed newborns/infants are anticipated.
Tabulated list of adverse reactions
System Organ Class
(cannot be estimated from the available data)
Immune system disorders
Skin and subcutaneous tissue disorders
Skin atrophy, often irreversible, with thinning of the epidermis
Dermatitis and eczema, including contact dermatitis
*See also 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.
Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically.
Pharmacotherapeutic group: Corticosteroid, ATC code: D07AB02
The active constituent, hydrocortisone butyrate, is an established topical corticosteroid, equi-efficacious with those corticosteroids classified as potent.
In human in-vivo studies, the potency of this form of active ingredient has been shown to be of the same order as other topical corticosteroids classed as potent. The active ingredient metabolises to hydrocortisone and butyric acid.
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.
Theoretically, there is the possibility that if maternal systemic absorption occurred the infant's adrenal function could be affected.
Macrogol cetostearyl ether
White soft paraffin
Anhydrous citric acid
Do not store above 25°C.
White opaque low density polyethylene bottles of 15 g, 25 g, 30 g, 50 g and 100 g capacity, equipped with a natural low density polyethylene dropper applicator, closed with a white polypropylene screw cap.
Not all pack sizes may be marketed.
No special requirements.
LEO Pharma A/S
Date of first authorisation: 23 May 1995
Date of latest renewal: 24 August 2010
22 January 2020
Horizon, Honey Lane, Hurley, Berkshire, SL6 6RJ, UK
+44 (0)1844 347 333