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BOOTS BITE AND STING RELIEF HYDROCORTISONE CREAM

Active substance(s): HYDROCORTISONE ACETATE / HYDROCORTISONE ACETATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Bite and Sting Relief Hydrocortisone Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone Acetate BP 1.0% w/w

3

PHARMACEUTICAL FORM
A smooth, white cream

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Insect bite and sting reactions

4.2

Posology and method of administration
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.

4.3

Contraindications
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.

4.4

Special warnings and precautions for use
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.

4.5

Interaction with other medicinal products and other forms of interaction
None known.

4.6

Pregnancy and lactation
This product should not be used in pregnancy without medical advice. There is
no information about effects on lactation.

4.7

Effects on ability to drive and use machines
None known.

4.8

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

4.9

Overdose
No special precautions or antidotes are likely to be needed.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Hydrocortisone is a corticosteroid which has anti-inflammatory activity.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
There are no preclinical safety data of relevance to the consumer.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
White soft paraffin
Liquid paraffin
Phenoxyethanol
Purified water
Cetomacragol emulsifying wax

6.2

Incompatibilities
None known.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Do not store above 25 C.

6.5

Nature and contents of container
Internally lacquered collapsible aluminium membrane-sealed tube with a
polypropylene cap. Pack size is 10g.

6.6

Special precautions for disposal
None

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0658

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/01/2008

10

DATE OF REVISION OF THE TEXT
30/01/2008

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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