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Napiers Marshmallow Skin Salve

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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/Sulphur Sublimed 1.3 % 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