Benadryl Skin Allergy Relief Cream

1. Name Of The Medicinal Product

Benadryl Skin Allergy Relief Cream

Benadryl Allergy Skin Cream

2. Qualitative And Quantitative Composition

Benadryl Allergy Skin Cream contains:

1% w/v diphenhydramine hydrochloride Ph Eur

8% w/v zinc oxide Ph Eur

0.1% w/v racemic camphor Ph Eur.

3. Pharmaceutical Form

Cream.

4. Clinical Particulars

4.1 Therapeutic Indications

Benadryl Allergy Skin Cream is indicated for the relief of irritation associated with urticaria, herpes zoster and other minor skin affections and alleviate the discomforts of sunburn, prickly heat, insect bites and nettle stings. In infants it may be used for hives.

4.2 Posology And Method Of Administration

Adults:

Topical. Benadryl Allergy Skin Cream may be applied to the affected area, three or four times daily.

Children and Infants:

Topical. As for adults.

The Elderly:

Topical. As for adults.

4.3 Contraindications

Do not use on chicken pox or measles or exudative dermatoses, unless supervised by a doctor. Do not use on extensive areas of the skin except as directed by a doctor. Do not use any other drugs containing diphenhydramine while using this product.

4.4 Special Warnings And Precautions For Use

Benadryl Allergy Skin Cream should not be applied to raw, or broken surfaces or mucous membranes as this may result in percutaneous absorption giving rise to systemic effects. Avoid contact with the eyes. If a burning sensation or rash develops or if the condition persists, treatment should be discontinued. If necessary, remove by washing with soap and water.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

The safety of Benadryl Allergy Skin Cream in pregnancy and lactation has not been established. Like any medicine, Benadryl Allergy Skin Cream should only be used if the possible benefits outweigh the potential risks involved. Diphenhydramine is known to be absorbed through the skin. Diphenhydramine crosses the placental barrier and is secreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Rarely, sensitivity, eczematous reactions and photosensitivity have been reported after topical application of antihistamines. If this occurs, treatment should be discontinued.

4.9 Overdose

Symptoms and signs

Accidental ingestion or excessive absorption of Benadryl Allergy Skin Cream may lead to dose-related signs of diphenhydramine toxicity. These include drowsiness and sedation with anti-cholinergic symptoms prevailing. Camphor may produce nausea, vomiting and dizziness. At higher doses, delirium leading to coma, ataxia, increased muscle reflexes and cloniform convulsions may appear.

Treatment

The stomach should be emptied by lavage and aspiration. In cases of acute poisoning, activated charcoal may be useful. A sodium sulphate purgative may be given. Convulsions may be controlled with diazepam or thiopental sodium. In the case of camphor poisoning, lipid haemodialysis or resin haemoperfusion may be useful.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Benadryl Allergy Skin Cream contains diphenhydramine hydrochloride, zinc oxide and camphor. Diphenhydramine is a powerful antihistamine and local anaesthetic (antipruritic). In concentrations of between 0.1 – 3.0 %, camphor depresses cutaneous receptors and is an effective analgesic, anaesthetic and antipruritic, which provides a feeling of coolness when applied topically.

5.2 Pharmacokinetic Properties

Benadryl Allergy Skin Cream is intended only for topical application to the skin. At the recommended dose little of the active ingredients will be absorbed. Percutaneous penetration of diphenhydramine and camphor has been demonstrated during inappropriate use of these compounds separately, but has not been quantified.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

White ceresin

Cetostearyl alcohol

Ferric oxide red (E172)

Ferric oxide yellow (E172)

Sorbitan stearate

Propyl hydroxybenzoate

Propylene glycol

Polysorbate 60

Perfume oil soleil 78087

Purified water

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

Benadryl Allergy Skin Cream is stored in a 42 g epoxy phenolic-based lacquered aluminium tube with a white, polyethylene or polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

None applicable.

Administrative Data

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0078

9. Date Of First Authorisation/Renewal Of The Authorisation

5^th January 2000

10. Date Of Revision Of The Text

2 December 2009