DERMASAFE DEEP RUB OINTMENT

Country: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

Menthol; Methyl salicylate

Fáanlegur frá:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (Alþjóðlegt nafn):

Menthol; Methyl salicylate

Einingar í pakka:

30 gm; 500 gm

Framleitt af:

IDAMAN PHARMA MANUFACTURING SDN BHD

Upplýsingar fylgiseðill

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DERMASAFE DEEP RUB OINTMENT
Methyl Salicylate / Menthol (25% w/w / 5% w/w)
1
WHAT IS IN THIS LEAFLET
1. What Dermasafe Deep Rub Ointment
is used for
2. How Dermasafe Deep Rub Ointment
works
3. Before you use Dermasafe Deep Rub
Ointment
4. How to use Dermasafe Deep Rub
Ointment
5. While you are using Dermasafe Deep
Rub Ointment
6. Side Effects
7. Storage and Disposal of Dermasafe
Deep Rub Ointment
8. Product Description
9. Product Registration Holder and
Manufacturer
10. Date of Revision
WHAT DERMASAFE DEEP RUB OINTMENT
IS USED FOR
It is used for relief of minor aches and
pains associated with:
• Muscular pain and stiffness in simple
backache
• Lower back pain
• Joint pain
• Rheumatic conditions such as pain,
swelling, stiffness and limited
movement in joints, muscles and
ligaments and other related condition.
HOW DERMASAFE DEEP RUB OINTMENT
WORKS
This
ointment
contains
2
active
ingredients which are Methyl Salicylate
and
Menthol.
They
work
together
to
soothe and relieve minor pains.
BEFORE YOU USE DERMASAFE DEEP RUB
OINTMENT
_- When you must not use it_
If you are allergy (hypersensitive) to any
of ingredients in Dermasafe Deep Rub
Ointment.
_- Before you start use it_
Do not use Dermasafe Deep Rub
Ointment on:
• Infants below 2 years of age.
• Avoid direct application into nostrils.
There have been reports of cessation of
breathing especially during sleep and
instant collapse in infants following the
local
application
of
menthol
to
their
nostril.
• Individuals with aspirin or salicylate
habit.
• Individuals taking warfarin, excessive
application onto the skin for muscle or
joint pains may increase the chances of
bleeding.
• Children suffering from flu,
chickenpox, or fever should avoid using
this
product
because
salicylates
may
induce Reyes Syndrome.
• Avoid contact with the eyes and mucous
membranes.
• Do not apply to open wounds or
damaged skin.
• Avoid excessive use during pregnancy
and lactation.
• Do not apply over large areas of th

Vara einkenni

DERMASAFE DEEP RUB OINTMENT
PRODUCT DESCRIPTION
A white to pale yellow coloured ointment with a pleasant
odour.
Each gram contains:
Methyl Salicylate 25%
w/w Menthol 5% w/w
ROUTE OF ADMINISTRATION
Topical
PHARMACODYNAMICS
Methyl
salicylate
is
a
salicylic
derivative.
It
inhibits
cyclooxygenase,
thereby
reducing
the
formation
of
prostaglandins,
and
cause
platelet
dysfunction.
Methyl
salicylate
is
used
topically
as
a
counter-irritant.
Upon
application, it is absorbed through the skin and is applied for
the relief of pain in rheumatic conditions and painful muscle
or joints.
When applied to the skin menthol dilates the blood vessels
causing a sensation of coldness followed by an analgesic
effect.
Menthol
also
acts
as
a
penetration
enhancer,
increasing the penetration of drugs when applied on the skin,
to give a faster onset of action.
PHARMACOKINETICS
_Methyl salicylate _
•
May be absorbed through intact skin.
•
The absorption of topical salicylates is proportional to the
surface area involved, duration of exposure, concentration
and skin integrity.
•
Absorption characteristics of salicylates vary with the dose,
formulation and route of administration.
•
Percutaneous absorption is enhanced by exercise, heat,
occlusion,
or
disruption
of
the
integrity
of
the
skin
or
application to large areas of skin.
•
Both the rate and extent of absorption increases after
repeated application; increasing the bioavailability.
•
Methyl salicylate is extensively metabolized to salicylic acid
in
the dermal
and
subcutaneous
tissues
after
topical
application.
•
At
therapeutic
levels,
the
half-life of
salicylates
is
2-4
hours. As salicylate level increase into the toxic range, the
half-life can be greater than 18 hours.
_Menthol _
•
After absorption, menthol is excreted in the urine and bile
as a glucuronide.
INDICATION
For the relief of minor aches and pains of muscles and joints
associated
with
simple
backache,
arthritis
and
rheumatic
conditions.
RECOMMENDED DOSAGE
_ADULTS & CHILDREN ABOVE 2 YEARS OLD: _
Apply to the affec