Tiger Balm White ointment

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

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환자 정보 전단 환자 정보 전단 (PIL)
07-06-2018
제품 특성 요약 제품 특성 요약 (SPC)
07-06-2018

유효 성분:

Cajuput oil; D-camphor; Menthol; Clove oil

제공처:

Omega Pharma Ltd

ATC 코드:

n/a

INN (International Name):

Cajuput oil; D-camphor; Menthol; Clove oil

복용량:

130mg/1gram ; 110mg/1gram ; 80mg/1gram ; 15mg/1gram

약제 형태:

Cutaneous ointment

관리 경로:

Cutaneous

수업:

No Controlled Drug Status

처방전 유형:

Never Valid To Prescribe As A VMP

제품 요약:

BNF: 10030200; GTIN: 5014713100105 5014713100303

환자 정보 전단

                                Marketing Authorisation Holder:
Omega Pharma Limited, 32 Vauxhall Bridge Road, London, SW1V 2SA, UK
Chefaro Ireland DAC, Treasury Building, Lower Grand Canal Street,
Dublin 2,
Ireland
This leaflet was last approved in November 2016.
PL: 02855/0235
PA: 1186/14/2
P1U0106 11
LF08489B
105 mm
220 mm
105 mm
Manufacturer (site of batch release in the EEA): Omega Pharma
International,
Venecoweg 26, B-9810 Nazareth, Belgium.
Read all of this leaflet carefully because it contains important
information
for you.
This medicine is available without prescription. However, you still
need to
use Tiger Balm White carefully to get the best results from it.
Keep this leaflet, you may wish to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your muscular aches and pains worsen or
do not improve after 2 weeks or if your headaches last for 24 hours or
keep coming back over the next week.
If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Tiger Balm is and what it is used for
2. What you need to know before you use Tiger Balm
3. How to use Tiger Balm
4. Possible side effects
5. How to store Tiger Balm
6. Contents of the pack and other information
1. WHAT TIGER BALM IS AND WHAT IT IS USED FOR
Tiger Balm can be used by adults and children over 2 years of age to
give temporary relief from minor muscular aches and pains.
Tiger Balm can also be used by adults only for the treatment of
tension
headache. This is the kind of headache that you may get when your
head, neck and shoulder muscles become tense due to tiredness,
overwork or emotional strain. If you are not sure whether you have a
tension headache contact your doctor or pharmacist for advice.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TIGER BALM
Do not use Tiger Balm
If you are allergic (hypersensitive) to camphor, menthol, clove oil or
cajuput oil or any of the other ingredients of Tiger Balm (listed in
Section 6).
If y
                                
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제품 특성 요약

                                OBJECT 1
TIGER BALM WHITE
Summary of Product Characteristics Updated 04-Apr-2016 | Omega Pharma
Ltd
1. Name of the medicinal product
Tiger Balm White.
2. Qualitative and quantitative composition
INGREDIENT
Camphor Ph Eur
Menthol Ph Eur
Cajuput Oil BPC
Clove Oil Ph Eur
% W/W
11.0% w/w
8.0% w/w
13.0% w/w
1.5% w/w
3. Pharmaceutical form
Ointment for cutaneous use.
4. Clinical particulars
4.1 Therapeutic indications
_Adults and children over 2 years:_
For the symptomatic relief of minor muscular aches and pains. Do not
use on children under 2 years.
_Adults only_:
For the treatment of tension headache.
4.2 Posology and method of administration
_Muscular aches and pains (Adults and children over 2 years):_
To be rubbed gently on the affected parts of skin as necessary
(usually 2 to 3 times daily). If symptoms
persist after two weeks, a doctor should be consulted (see section
4.4). Do not use on children under two
years of age.
_Tension headache (Adults only):_
Rub the ointment onto the forehead or temples and lightly massage in a
circular motion. Use a pea-sized
quantity of ointment (approximately 0.5g or less), sufficient to
lightly cover the affected area.
Tiger Balm White Ointment should only be applied to the forehead or
the temples. Do not use in children.
4.3 Contraindications
Hypersensitivity to any of the ingredients in this product.
Asthma or other diseases of the respiratory tract that involve
hypersensitivity of the airways.
Skin disease, open wounds, inflamed or irritated skin.
Use in infants and children under 2 years, due to the risk of
respiratory collapse.
_Non tension headache_. Non tension headaches include those associated
with nausea, vomiting and
dizziness; visual disturbance; a unilateral headache; a headache
presenting on wakening from sleep and/or
following strenuous exercise.
4.4 Special warnings and precautions for use
For external use only. Wash hands immediately after use. Do not apply
to wounds, damaged or irritated
skin, discontinue use if irritation develops. Avoid contact with the
eyes,
                                
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