Menthol & Wintergreen Cream

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Turpentine oil; Oleoresin capsicum; Methyl salicylate; Levomenthol

Доступно од:

Ovelle Limited

АТЦ код:

M02AC

INN (Међународно име):

Turpentine oil; Oleoresin capsicum; Methyl salicylate; Levomenthol

Дозирање:

5% w/w + 0.2% w/w + 2% w/w + 13.18 percent weight/weight

Фармацеутски облик:

Cream

Тип рецептора:

Product not subject to medical prescription

Терапеутска област:

Preparations with salicylic acid derivatives

Статус ауторизације:

Marketed

Датум одобрења:

1988-09-01

Информативни летак

MENTHOL AND WINTERGREEN CREAM
Methyl Salicylate 5.00%w/w, Levomenthol 2.00%w/w, Oleoresin Capsicum
0.20%w/w,
Turpentine Oil 13.18%w/w
PATIENT INFORMATION LEAFLET
_READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU. _
_ _
This medicine is available without a prescription. Nevertheless you
will still need to use
Menthol and Wintergreen Cream carefully to get the best results from
it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not included in this leaflet. See section 4.

You must see a doctor if your symptoms do not improve after using
Menthol and
Wintergreen Cream.
_IN THIS LEAFLET: _
1.
What Menthol and Wintergreen Cream is and what it is used for
2.
Before you use Menthol and Wintergreen Cream
3.
How to use Menthol and Wintergreen Cream
4.
Possible side effects
5.
How to store Menthol and Wintergreen Cream
6.
Further information
1.
WHAT MENTHOL AND WINTERGREEN CREAM IS AND WHAT IT IS USED
FOR
The name of your treatment is Menthol and Wintergreen Cream. It is a
pale peach-
coloured topical cream.Menthol and Wintergreen Cream contains Methyl
salicylate
5.00%w/w, Levomenthol 2.00%w/w, Oleoresin capsicum 0.20%w/w and
Turpentine oil
13.18%w/w as the active ingredients. Menthol and Wintergreen Cream is
used to relieve
the symptoms of muscular pains, rheumatic pain, fibrositis, strains
and lumbago.
2.
BEFORE YOU USE MENTHOL AND WINTERGREEN CREAM
_DO NOT USE MENTHOL AND WINTERGREEN CREAM _

On mucous membranes (e.g. nostrils, mouth, lips, ears, eyelids and
genital area) or
broken skin,

On children under 16 years of age due to the presence of salicylates

If you are allergic to methyl salicylate, levomenthol, oleoresin
capsicum, turpentine oil
or any of the other ingredients of this medicine which are liquid
paraffin, cetostearyl
alcohol, sodium laurilsulfate, sunset yellow (E110) and purified
w

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Menthol & Wintergreen Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients % w/w
Methyl salicylate 5.00
Oleoresin capsicum 0.2
Levo Menthol 2.00
Turpentine oil 13.18
Excipients:
Cetostearyl alcohol is present at 4.50% w/w.
E487 sodium laurilsulfate is present at 0.47 % w/w
Sunset Yellow (E110) is present at 0.004%w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A pale peach-coloured topical cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the local management of the symptoms of fibrositis, muscle strains
and arthroses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical to the affected area. Massage into affected part until
absorbed. Repeat several times daily for continued relief.
This product should not be applied to neonates, infants or children
under 16 years of age.
4.3 CONTRAINDICATIONS
Not to be applied to mucous membranes or broken skin or children under
16 years of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Wash hands thoroughly after applying. Avoid contact with the eyes,
broken skin or mucous membranes. If the
condition is aggravated or there is no improvement, consult the
doctor. E110 may cause allergic reactions.
Cetostearyl alcohol may cause local skin reactions (e.g. contact
dermatitis).
Sodium laurilsulfate (E 487) may cause local skin reactions (such as
stinging or burning sensation) or increase skin
reactions caused by other products when applied on the same area.
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