SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Witch Doctor 81.5%w/w Gel

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Contains Liquid Extract of Witch Hazel 81.539% w/w For excipients, see 6.1.

3    PHARMACEUTICAL FORM

Gel

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Itching, insect bites, stings, sunburn, minor burns, grazes, personal irritation, chafing, minor rashes and skin irritations.

4.2    Posology and method of administration

Squeeze gel directly onto affected area. Smooth over gently. Allow to dry.

4.3    Contraindications

Do not use in eyes.

4.4    Special warnings and precautions for use

If symptoms persist consult doctor.

Keep out of reach of children.

4.5    Interaction with other medicinal products and other forms of interaction

None known

4.6    Pregnancy and lactation

Not applicable

4.7    Effects on ability to drive and use machines

Not applicable

4.8    Undesirable effects

None stated.

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 www.yellowcard.mhra.gov.uk

4.9 Overdose

Not applicable

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Liquid Extract Witch Hazel - Astringent.

Ethanol - bactericidal, antiseptic and disinfectant, astringent and skin cooling properties.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol

Propylene glycol Triethanolamine Carbomer Disodium Edetate Menthol

Lauric acid diethanolamide Green S (E 142)

Witch Hazel essence

6.2 Incompatibilities

None stated.

6.3 Shelf life

6.4    Special precautions for storage

Store below 25°C

6.5    Nature and contents of container

35gm Tube-    All plastic laminate

6.6    Special precautions for disposal

Not applicable

7    MARKETING AUTHORISATION HOLDER

Lornamead UK Limited

Sabre House

377-399

Camberley

Surrey

GU15 3HL

8    MARKETING AUTHORISATION NUMBER(S)

PL 35207/0001

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08/11/2005

10 DATE OF REVISION OF THE TEXT

11/03/2015