Teangi Tea Tree And Witch Hazel Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teangi Tea Tree and Witch Hazel Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Ingredients |
%w/w |
|
Eucalyptus Oil |
1.04 |
|
Distilled Witch Hazel |
40.61 |
|
Methyl Salicylate |
1.04 |
|
Camphor |
0.52 |
|
Zinc Oxide |
3.11 |
|
Tea Tree Oil |
2.50 |
Excipient: Wool Fat
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
Smooth white cream.
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.
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 PHARMACOLOGICAL PROPERTIES
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.
6.1 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
G. R. Lane Health Products Limited Sisson Road
Gloucester
GL2 0GR
United Kingdom
Tel: +44 (0)1452 524012
Fax: +44 (0)1452 507930
Email: info@laneshealth.com
8. Marketing Authorisation Number
PL 01074/5033R.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25 October 1989.
Date of latest renewal: 19 July 2006.
10 DATE OF REVISION OF THE TEXT
02/06/2014