TEANGI TEA TREE AND WITCH HAZEL CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Teangi Tea Tree and Witch Hazel Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

3   PHARMACEUTICAL FORM

4   CLINICAL PARTICULARS

4.1 Therapeutic indications

(i) For the relief of minor skin conditions including dry chapped skin, nappy rash and sunburn.

(ii) For the treatment of cuts, minor burns and wounds.

4.2 Posology and method of administration

For cutaneous use.

Apply generously to the affected area several times daily when needed and at bedtime.

For cuts and wounds, wash area first.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.

4.4 Special warnings and precautions for use

If symptoms worsen or do not improve after 7 days, a doctor should be contacted.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

4.5 Interaction with other medicinal products and other forms of interaction

Zinc oxide is reported to be incompatible with benzyl penicillin. However, since this product is used topically, and benzyl penicillin is administered intravenously, there is unlikely to be any interactions if both products are used concomitantly.

4.6 Pregnancy and lactation

In the absence of sufficient data the use during pregnancy and lactation is not recommended.

4.7 Effects on ability to drive and use machines

This product has no influence on the ability to drive and use machines.

4.8 Undesirable effects

The product is generally well tolerated. Hypersensitivity reactions may rarely occur (manifested as skin rashes).

4.9 Overdose

No cases of overdose have been reported.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other Dermatological Preparations, ATC code: D11A X

(i) Camphor – Counter irritant and mild analgesic when used topically.

(ii) Zinc Oxide – mild astringent and protective for slight excoriations.

(iii) Distilled Witch Hazel – local astringent and haemostatic. Cooling application for sprains and bruises.

(iv) Eucalyptus Oil – Counter irritant and mild analgesic when used topically.

(v) Methyl Salicylate – Has analgesic properties. It is readily absorbed through the skin and relieves pain in rheumatic conditions

(vi) Tea Tree Oil – disinfectant.

5.2 Pharmacokinetic properties

No data.

5.3 Preclinical safety data

Camphor: Camphor toxicity usually arises from ingestion, particularly in children. If used in accordance with the directions then problems are unlikely.

Zinc Oxide: Zinc Oxide toxicity usually arises from ingestion or inhalation, particularly in children. If used in accordance with the directions then problems are unlikely.

Distilled Witch Hazel: Distilled Witch Hazel toxicity usually arises from ingestion in susceptible patients. If used in accordance with the directions then problems are only likely in susceptible patients.

Eucalyptus Oil: Eucalyptus Oil toxicity usually arises from ingestion, particularly in children. If used in accordance with the directions then problems are unlikely.

Methyl Salicylate: Methyl Salicylate toxicity is as for aspirin. Problems may include hypersensitivity resulting from skin eruptions. Salicylates have been shown to cross the placenta and have shown teratogenicity in animals. Salicylates are also believed to be implicated in the onset of Reyes Syndrome in children.

Tea Tree Oil: Tea Tree Oil is mildly toxic when ingested. It is a very mild irritant of human skin and is non-sensitising and non-toxic.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Beeswax, White

Chloroxylenol

Emulsifying Wax

Levomenthol

Water

White Soft Paraffin

Wool Fat

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

12 months

6.4. Special Precautions for Storage

Do not store above 25oC

6.5 Nature and contents of container

28g in a collapsible aluminium tube fitted with a plastic cap, and 30g in a glass jar fitted with a plastic cap.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

8.    Marketing Authorisation Number

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

Date of first authorisation: 25 October 1989.

Date of latest renewal:       19 July 2006.