Summary of Product Characteristics Updated 22-Sep-2023 | THE BOOTS COMPANY PLC
Boots Bite and Sting Relief Hydrocortisone Cream
Hydrocortisone Acetate BP 1.0% w/w
A smooth, white cream
Insect bite and sting reactions
For topical administration.
Apply sparingly to a small area, once or twice a day, for a maximum of 2-3 days. Do not use in pregnancy without medical advice or in children under 10.
Hypersensitivity to hydrocortisone acetate or to any other excipients listed in section 6.1
The product should not be used on the eyes or face, the ano-genital area or on broken or infected skin including impetigo, cold sores, acne, athlete's foot, scabies or infected bites or stings.
In the presence of untreated infections of bacterial, viral, tuberculous or fungal origin.
Not for use with an occlusive dressing or on large areas of the body.
The product should not be used during pregnancy or breast-feeding unless recommended by a health care professional (see section 4.6).
The product labelling shall include the following statements:
If the condition does not improve consult your doctor. Do not use on the eyes or face, anal or genital areas or on broken skin or infected skin, e.g. impetigo, cold sores, acne, athlete's foot, scabies or infected bites or stings. Do not use for other bites or stings or for other skin conditions.
Visual impairment may be reported with systemic and topical use of corticosteroids. If patients develop symptoms such as blurred vision or other visual disturbances, consideration should be given to referring the patient to an ophthalmologist to establish the possible cause which may include cataract, glaucoma or rare conditions such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
This product should not be used in pregnancy without medical advice. There is no information about effects on lactation.
This product should not be used whilst breast-feeding unless recommended by a health care professional. Corticosteroids are excreted in human milk. There is no information about effects on lactation. A risk to new-borns/infants cannot be excluded.
Treatment with hydrocortisone is usually well tolerated but treatment should be stopped if symptoms of hypersensitivity occur, including allergic contact dermatitis or worsening of the original condition.
Frequency not known: blurred vision (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.
No special precautions or antidotes are likely to be needed.
Hydrocortisone is a corticosteroid which has anti-inflammatory activity.
There are no preclinical safety data of relevance to the consumer.
White soft paraffin
Cetomacrogol emulsifying wax
Do not store above 25°C.
Internally lacquered collapsible aluminium membrane-sealed tube with a polypropylene cap. Pack size is 10g.
The Boots Company PLC
1 Thane Road West
13th September 2023
1 Thane Road West, Beeston, Nottingham, NG2 3AA
+44 (0)1159 592 565
+44 (0)1159 595 165