Napiers Marshmallow Skin Salve
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Marshmallow Skin Salve Box's Herbals Woodsap Skin Balm
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Marshmallow Root (Althea officinalis L.), 6.5 % w/w Slippery Elm Bark (Ulmus fulva L. ), 2.5 % w/w Sulphur Sublimed 1.3 % w/w Zinc Oxide 1.95 % w/w
Each gram of ointment contains 11 mg Lanolin (W ool fat) and 11 mg Cetostearyl alcohol (See Section 4.4. ‘Special warnings and precautions for use’)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pale green ointment
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of minor skin conditions causing skin irritation such as dermatitis and mild eczema, 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 of age: Apply to affected skin sparingly once at night and once in the morning.
If symptoms worsen or persist after 2 weeks, consult a doctor or a qualified healthcare practitioner.
4.3 Contraindications
Hypersensitivity to the active ingredients or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Avoid contact with eyes or mucous membrane.
Do not use this product and consult your doctor or qualified healthcare practitioner if you have widespread redness, oozing or infected skin sores, if the skin is broken or if the affected area has suddenly become inflamed.
If symptoms worsen or persist after 2 weeks, a doctor or a qualified healthcare practitioner should be consulted.
This product contains Lanolin. (Wool fat) and Cetostearyl alcohol. May cause local skin reactions (e.g. contact dermatitis)
The use in children under 12 years is not recommended because data are insufficient and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
No studies have been carried out to determine if drug interactions occur with this product.
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
No studies on the effect on the ability to drive and 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.
4.9 Overdose
No cases have been reported with this product.
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 reproductive toxicity, genotoxicity and carcinogenicity have not been
performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Eucalyptus oil Rosemary oil Castor oil
Chlorophyll oil soluble E140 Soft Yellow Paraffin Wool Fat (Lanolin anhydrous)
Cetostearyl alcohol Hard Paraffin
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25oC. Store in the original container.
6.5 Nature and contents of container
Aluminium Tin or Plastic Container: 50g
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Highland Herbs Limited 10 Payne Street Glasgow G4 0LF
8 MARKETING AUTHORISATION NUMBER(S)
THR 43751/0013
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/04/2013
10 DATE OF REVISION OF THE TEXT
21/01/2015