Potters Skin Clear Tea Tree Ointment
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potter’s Skin Clear Tea Tree Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of ointment contains:
0.1 % w/w Tea Tree Oil (Melaleuca alternifolia (Maiden and Betche) Cheel)
23.0 % w/w Zinc Oxide
5.0 % w/w Sublimed Sulphur
For full list of excipients see Section 6.1
3 PHARMACEUTICAL FORM
Cutaneous ointment.
Cream coloured ointment
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of minor skin conditions such as spots, pimples, and blemishes, based on traditional use only.
4.2 Posology and method of administration
For cutaneous use only.
Wash hands before and after use.
Adults, the elderly and children over 12 years: Apply ointment sparingly once in the morning and once at night.
Not recommended for children under 12 years of age. (See section 4.4 ‘Special warnings and precautions for use’).
If symptoms worsen or persist for more than 2 weeks a doctor or a qualified health care practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredients or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Avoid contact with eyes and mucous membranes.
Do not use on broken or irritated skin.
If symptoms worsen or if signs of infection are observed or if symptoms do not improve after 2 weeks a doctor or a qualified health care practitioner
should be consulted.
Discontinue use if skin reaction, irritation or dry skin occurs and consult a doctor or a qualified health care practitioner.
Not recommended for children under 12 years of age because data are not sufficient and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established. Therefore in the absence of sufficient data, the use of this product during pregnancy and lactation is not recommended.
Studies on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive or use machines have been performed
4.8 Undesirable effects
None known.
If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.
Overdose
4.9
No case of overdose has been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Yellow Soft Paraffin Maize Starch
6.2 Incompatibilities
None
6.3 Shelf life
3 years
6.4
Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
Amber glass jar with hard plastic screwcap: 30 g and 55 g. Double-wall plastic jar with hard plastic screwcap: 30 g and 55 g. Polypropylene jar with polypropylene closure: 40 g, 50 g and 55 g. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Vifor Pharma UK Ltd 1 Botanic Court,
Martland Park,
Wigan,
WN5 0JZ,
UK.
Trading as: Potters, Wigan WN5 0JZ
8 MARKETING AUTHORISATION NUMBER(S)
THR 33656/0065
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/04/2013
10 DATE OF REVISION OF THE TEXT
12/04/2013