HYDROCORTISONE Cream Ref.[7550] Active ingredients: Hydrocortisone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Actavis UK Limited (Trading style: Actavis), Whiddon Valley, Barnstaple, North Devon, EX32 8NS

Therapeutic indications

Hydrocortisone has topical anti-inflammatory activities of value in the treatment of various dermatological conditions including:

  • Eczema- atopic, infantile, discoid or stasis
  • Dermatitis- primary irritant, contact allergic, photo or seborrhoeic
  • Insect bite reactions
  • Prurigo nodularis
  • Neurodermatoses
  • Otitis externa
  • Intertrigo
  • Napkin rash, where concurrent infection is excluded or being addressed

Hydrocortisone Cream 0.5% can be used as continuation therapy in mild cases of seborrhoeic or atopic eczema once the acute inflammatory phase has passed.

Posology and method of administration

Posology

Adults (including elderly)

Gently apply a thin layer of cream to the affected area two or three times daily.

Children and infants

Gently apply a thin layer of cream to the affected area two or three times daily. Avoid prolonged use. In infants, therapy should be limited to five to seven days.

Hydrocortisone cream is usually suitable for moist or weeping surfaces, whereas the ointment formulation should be considered for dry, scaly or lichenified conditions.

Method of Administration

For topical application.

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.

Shelf life

Shelf life: a 24 month shelf life.

After dilution or reconstitution: Not applicable.

After first opening: Not applicable.

Special precautions for storage

Store below 25°C; do not freeze.

Nature and contents of container

The product containers are aluminium tubes with screw caps contained in cartons:

Carton: White backed folding box board printed two colours on white.

Tube: Manufactured from 99.5% pure aluminium; lacquered internally, printed externally on white.

Pack sizes: 15g, 30g, 50g.

Special precautions for disposal and other handling

Not applicable.

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