Nelsons Arnicare Arnica Cream

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Arnica montana

제공처:

A. Nelson & Company Limited

INN (국제 이름):

Arnica montana

복용량:

1X (0.9) percent weight/weight

약제 형태:

Cream

처방전 유형:

Product not subject to medical prescription

승인 상태:

Marketed

승인 날짜:

2018-11-09

환자 정보 전단

IRELAND ARNICA CREAM 30g
3001919 v9
10/09/2018
3001919
EXP:
LOT NO:
DIRECTIONS
For use on the skin only.
Before first use check
tube seal is not broken.
Pierce tube seal with point
in top of cap before use.
Adults, the elderly and
children over 2 years:
Wash hands before and
after use.
Apply to the affected area
4 times a day, as required.
Do not use more cream
than the label/leaflet tells
you to.
Use by 3 months from the
date of opening.
PRECAUTIONS
Do not use this product if
you are allergic to any of
the ingredients or to
plants of the Asteraceae/
Compositae family (such
as daisies, marigolds or
artichokes).
Do not use this product
if you are pregnant or
breastfeeding.
Do not apply to broken
or irritated skin.
Keep away from eyes,
mouth and nose.
If symptoms worsen, or
persist for more than
two weeks, a doctor or
a qualified healthcare
practitioner should be
consulted.
Keep all medicines out
of the sight and reach
of children.
30g
ACTIVE INGREDIENT
Arnica montana tincture
1X (0.9% w/w)
ALSO CONTAINS
Purified water, Glyceryl
monostearate &
Macrogol stearate,
Apricot kernel oil,
Theobroma oil, Glycerol
(E422), Cetostearyl
alcohol & PEG-20
Stearate, Cetostearyl
alcohol, Cetyl
palmitate, Glyceryl
monocaprylate, Methyl
parahydroxybenzoate
(E218), Propyl
parahydroxybenzoate
(E216).
Please read the
enclosed package
leaflet before use.
For use on the skin
only.
Do not store above
25°C.
Do not use after expiry
date shown.
National rules
authorisation holder &
manufacturer:
A Nelson & Co Limited
5-9 Endeavour Way,
Wimbledon, London,
SW19 8UH, UK
HOA1149/008/001
NELSONS, the ellipse logo, the
leaf & cross logo, and ARNICARE,
are registered trade marks of
A Nelson & Co Limited.
®
Arnica montana 1X
A homeopathic medicinal product used within the
homeopathic tradition for the symptomatic relief of bruises
Arnica montana 1X
®
A homeopathic medicinal product used within the
homeopathic tradition for the symptomatic relief of bruises
Arnica montana 1X
®
BRAILLE:
nelsons arnicare arnica cream
®
®
IRELAND ARNICA CREAM 30g

제품 특성 요약

Health Products Regulatory Authority
15 November 2018
CRN008K80
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nelsons Arnicare Arnica Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream contains:
Arnica montana tincture 1X (0.9% w/w)
Excipients with known effect:
Cetostearyl alcohol 2.75% w/w
Propyl parahydroxybenzoate (E216) 0.15% w/w
Methyl parahydroxybenzoate (E218) 0.30% w/w
For the 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 homeopathic medicinal product used within the homeopathic tradition
for the
symptomatic relief of bruises.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only
Wash hands before and after use.
Adults, the elderly and children over 2 years: Apply to the affected
area 4 times a day,
as required.
Not recommended for children under 2 years.
If symptoms worsen or persist after using the product for two weeks, 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 listed in 6.1.
Health Products Regulatory Authority
15 November 2018
CRN008K80
Page 2 of 4
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed the stated dose
Avoid contact with eyes and mucous membranes.
Not to be applied to broken or irritated skin. Discontinue use if skin
becomes red, dry
or irritated.
This product is not recommended for children under 2 years of age and
medical
advice should be sought.
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
INTERACTIONS
None reported
No interaction studies have been performed.
4.6 FERTILITY, PREGNAN