Histergan Cream
Summary of product characteristics
1. Name of the medicinal product
Histergan Cream
Lloyds Pharmacy Antihistamine Cream
Boots Skin Allergy Relief 2% w/w Cream
Vantage Antihistamine 2.0% w/w Cream
Careway Antihistamine 2% w/w Cream
2. Qualitative and quantitative composition
Diphenhydramine Hydrochloride BP 2% w/w
3. Pharmaceutical form
Topical Cream
4.1. Therapeutic indications
Symptomatic treatment of allergic conditions e.g.:- Urticaria, pruritus, allergic rashes, stings and insect bites.
4.2. Posology and method of administration
Apply sparingly and infrequently (maximum twice daily) to the affected area. Short term treatment only - not more than three days.
Not recommended for children under six years old.
4.3. Contraindications
Known sensitivity to anti-histamines and benzoates. Do not apply to mucous membranes, eczematous conditions or where the skin is extensively broken or denuded, or in acute vesicular or exudative dermatoses. Do not use with any other product containing the same active ingredient.
4.4. Special warnings and precautions for use
Apply sparingly. Avoid prolonged use or repeated applications especially to large areas. If burning or rash develops, or if the condition persists, medical advice should be sought immediately. If necessary remove by washing with soap and water. Wash hands after use, unless they are being treated.
4.5. Interaction with other medicinal products and other forms of interaction
None recorded.
4.6. Fertility, pregnancy and lactation
Not applicable when used as directed. Medicament should only be used in pregnancy when anticipated benefits exceed the risks.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
May give rise to sensitisation reaction and photosensitivity. Rarely eczematous reactions have been reported, if this occurs, treatment should be discontinued.
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:
Website: www.mhra.gov.uk/yellowcard
4.9. Overdose
Accidental ingestion or excessive absorption may lead to dose related signs of diphenhydramine toxicity which includes drowsiness and sedation.
Treatment is by gastric lavage and aspiration. In cases of acute poisoning, activated charcoal may be useful.
5.1. Pharmacodynamic properties
Diphenhydramine applied externally has anti-histaminic activity in conditions induced by allergic stimuli.
5.2. Pharmacokinetic properties
Diphenhydramine is a histamine H1 receptor antagonist.
External applications to largely intact skin results in minimal systemic absorption.
5.3. Preclinical safety data
None stated.
6.1. List of excipients
Propyl Hydroxybenzoate, Liquid Paraffin, Emulsifying Wax, Deionised Water.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store between 4°C and 25°C.
6.5. Nature and contents of container
Tube 25g.
6.6. Special precautions for disposal and other handling
None stated.
7. Marketing authorisation holder
Norma Chemicals Ltd.
51-53 Stert Street
Abingdon
Oxfordshire OX14 3JF United Kingdom
8. Marketing authorisation number(s)
PL 00386/5000R
9. Date of first authorisation/renewal of the authorisation
4 December 1989 / 13 June 1995
10. Date of revision of the text
18th October 2017
4.1 Therapeutic indications
Symptomatic treatment of allergic conditions e.g.:- Urticaria, pruritus, allergic rashes, stings and insect bites.
4.2 Posology and method of administration
Apply sparingly and infrequently (maximum twice daily) to the affected area. Short term treatment only - not more than three days.
Not recommended for children under six years old.
4.3 Contraindications
Known sensitivity to anti-histamines and benzoates. Do not apply to mucous membranes, eczematous conditions or where the skin is extensively broken or denuded, or in acute vesicular or exudative dermatoses. Do not use with any other product containing the same active ingredient.
4.4 Special warnings and precautions for use
Apply sparingly. Avoid prolonged use or repeated applications especially to large areas. If burning or rash develops, or if the condition persists, medical advice should be sought immediately. If necessary remove by washing with soap and water. Wash hands after use, unless they are being treated.
4.5 Interaction with other medicinal products and other forms of interaction
None recorded.
4.6 Fertility, pregnancy and lactation
Not applicable when used as directed. Medicament should only be used in pregnancy when anticipated benefits exceed the risks.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
May give rise to sensitisation reaction and photosensitivity. Rarely eczematous reactions have been reported, if this occurs, treatment should be discontinued.
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:
Website: www.mhra.gov.uk/yellowcard
30 mins
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The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.
Medthority will not be held liable for explicit or implicit errors, or missing data.
Drug Licencing
Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).