Weleda Arnica Bumps and Bruises Skin Salve Ointment

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Доступна с:

Weleda (UK) Limited

код АТС:

M02AX; M02AX10

дозировка:

.

Фармацевтическая форма:

Ointment

Тип рецепта:

Product not subject to medical prescription

Терапевтические области:

Other topical products for joint and muscular pain; various

Статус Авторизация:

Marketed

Дата Авторизация:

2018-12-14

Характеристики продукта

Health Products Regulatory Authority
21 December 2018
CRN008K7L
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Weleda Arnica Bumps and Bruises Skin Salve Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of ointment contains:
0.10 ml of tincture (DER 1:2) from fresh Arnica montana L., planta
tota (Arnica whole
plant) (equivalent to 48 mg of fresh Arnica whole plant);
Extraction solvent: Ethanol 53% w/w
Excipients with known effect:
1 g of ointment contains 324 mg of Wool Fat (Lanolin)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Ointment.
A smooth, soft, cream to pale yellow ointment with a faint odour
characteristic of
Arnica.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the relief of muscular
aches, pain,
stiffness, sprains, bruises, swelling after contusions and minor
sports injuries.
Exclusively based on long-standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only.
Adults, the elderly and children:
Wash hands before and after use.
Muscular pain, stiffness, sprains, bruises and minor sports injuries:
apply sparingly to
the affected area with gentle massage three to four times daily.
Contusions: Apply a small amount immediately at the site of the injury
Duration of use
Do not use for more than one week.
Health Products Regulatory Authority
21 December 2018
CRN008K7L
Page 2 of 5
If symptoms worsen, persist or do not improve after one week of use of
Weleda
Bumps & Bruises Skin Salve Ointment a qualified healthcare
practitioner or health
professional eg a doctor or pharmacist should be consulted.
4.3 CONTRAINDICATIONS
Hypersensitivity to _Arnica montana_, other species of the Asteraceae
(Compositae)
family or any of the other ingredients of the product listed in
section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed the stated dose.
If symptoms worsen, persist or do not improve after one week, a doctor
or qualified
healthcare practitioner or health professiona