Nelsons Calendula Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nelsons Calendula Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains:
9.0% v/w tincture of Calendula flowers (Calendula officinalis L.) (1:10)
Extraction solvent: Ethanol 0.3 % v/w
Also contains Cetostearyl alcohol, propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218). (See section 4.4. Special warnings and precautions for use)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
A smooth white to off-white cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of sore and rough skin, 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 6 years: Apply liberally to affected area 4 times a day as required.
Not recommended for use in children under 6 years of age (See section 4.4. Special warnings and precautions for use)
If symptoms worsen or persist after using the product for 1 week, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredient or to plants of the Asteraceae (Compositae) family or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose
The use in children under 6 years of age is not recommended because there is no experience available.
Avoid contact with eyes and mucous membranes.
If signs of skin infection are observed, a doctor or a qualified healthcare practitioner should be consulted.
This product contains Cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
This product contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
4.5 Interaction with other medicinal products and other forms of interaction
None reported
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
Studies on the effects on the ability to drive or operate machines have not been performed.
4.8 Undesirable effects
Skin sensitisation. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
4.9 Overdose
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
Tests on genotoxicity, carcinogenicity and reproductive toxicity have not been performed.
Available tests on genotoxicity (liquid extract with 60% ethanol) and on carcinogenicity (undefined extract) did not give any reason for concern.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Purified water
Arlacel 170 (Glyceryl Stearate and PEG-100 Stearate) Apricot kernel oil Theobroma oil (Cocoa butter)
Glycerol
Polawax GP 200 (Cetearyl alcohol, PEG-20 Stearate) Cetostearyl alcohol Cetyl palmitate Glyceryl monocaprylate
Methyl parahydroxybenzoate E218 Propyl parahydroxybenzoate E216
Fragrance (Compo Cos: benzyl benzoate;propanol -oxybis; benzoate, 2,4-dihydro-3,6-dimethyl-, methyl; oils, oakmoss-resinoid)
6.2 Incompatibilities
None known.
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
Epoxy phenolic lacquered aluminium tube. Polyethylene cap. 30 g, 50g.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
A Nelson & Co Limited 5-9 Endeavour Way Wimbledon London SW19 8UH
Trading style: Nelsons Homeopathy
8 MARKETING AUTHORISATION NUMBER(S)
THR 01175/0400
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 24/04/2013
10
DATE OF REVISION OF THE TEXT
24/04/2013