PERSKINDOL CLASSIC GEL

Country: Malaysia

Language: English

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

Active ingredient:

LEVOMENTHOL (MENTHOL); Oil of Pine; ORANGE OIL; Wintergreen Oil; Bergamot Oil; LEMON OIL; Terpineol; Terpinyl acetate; ROSEMARY OIL; LAVENDER OIL

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

LEVOMENTHOL (MENTHOL); Oil of Pine; ORANGE OIL; Wintergreen Oil; Bergamot Oil; LEMON OIL; Terpineol; Terpinyl acetate; ROSEMARY OIL; LAVENDER OIL

Units in package:

100 ml; 4 ml; 50 ml

Manufactured by:

Glaropharm AG

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PERSKINDOL CLASSIC GEL
Levomenthol 1.500% w/w, Pine Sylvestris oil 1.350% w/w, Sweet Orange
oil 0.400% w/w, Wintergreen oil 0.350% w/w, Bergamot
oil 0.100% w/w, Lemon oil 0.100% w/w, Terpineol 0.100% w/w, Terpinyl
acetate 0.100% w/w, Rosemary oil 0.060% w/w,
Lavender oil 0.020% w/w
1
WHAT IS IN THIS LEAFLET
1.
What
PERSKINDOL
CLASSIC GEL is used for
2.
How
PERSKINDOL
CLASSIC GEL works
3.
Before you use PERSKINDOL
CLASSIC GEL
4.
How
to
use
PERSKINDOL
CLASSIC GEL
5.
While
you
are
using
PERSKINDOL
CLASSIC
GEL
6.
Side Effects
7.
Storage
and
Disposal
of
PERSKINDOL
CLASSIC
GEL
8.
Product Description
9.
Manufacturer
and
Product Registration
Holder
10.
Date of Revision
11.
Serial Number
WHAT PERSKINDOL CLASSIC
GEL IS USED FOR
PERSKINDOL
CLASSIC
GEL
is
used for relief of minor aches and
pains of muscles and joints associated
with
arthritis,
stiff
neck,
strains,
sprains,
bruises,
cramps,
simple
backache.
HOW
PERSKINDOL
CLASSIC
GEL WORKS
PERSKINDOL
CLASSIC
GEL
contains
the
active
ingredients
menthol and essential oils. Menthol
lowers the body temperature of the
affected area therefore numbing the
pain at once. The essential oils each
have stimulant actions, which help
promote the blood flow to the affected
area.
BEFORE
YOU
USE
PERSKINDOL
CLASSIC GEL
-
_When you must not use it_
Do
not
apply
PERSKINDOL
CLASSIC
GEL
to
wounds
or
damaged
skin.
Avoid
contact
with
eyes and mucous membranes. Do not
use PERSKINDOL CLASSIC GEL
when allergy reaction to one or more
essential oils is knows.
-
_Before you start to use it_
If you have sensitive skin, consult a
doctor before use.
_Pregnancy and breastfeeding _
As with any drug, if you are pregnant
or nursing a baby, seek the advice of
a health professional before using this
product.
-
_Taking other medicines_
None known.
HOW
TO
USE
PERSKINDOL
CLASSIC GEL
-
_How much to use_
Adults and children 6 years of age and
older: Apply to affected area not more
than
3
to
4
times
daily.
Gently
massage until Perskindol is absorbed.
Use only as directe

Summary of Product characteristics

CLASSIC
GEL
50 & 100 ML
113979/05
PACKAGE INSERT
BRAND OR PRODUCT NAME
PERSKINDOL CLASSIC GEL
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
INGREDIENTS
FORMULA
Levomenthol
1.50 % w/w
Pine Sylvestris oil
1.35 % w/w
Sweet Orange oil
0.40 % w/w
Wintergreen oil
0.35 % w/w
Bergamot oil
0.10 % w/w
Lemon oil
0.10 % w/w
Terpineol
0.10 % w/w
Terpinyl acetate
0.10 % w/w
Rosemary oil
0.06 % w/w
Lavender oil
0.02 % w/w
PRODUCT DESCRIPTION
Perskindol Classic Gel is a white to yellowish, homogeneous gel with
an aromatic odour of menthol and essential oils.
INDICATION
For relief of minor aches and pains of muscles and joints associated
with
arthritis, stiff neck, strains, sprains, bruises, cramps, simple
backache.
PHARMACODYNAMICS
_Rational for combination of activeingredients:_
a)
Menthol lowers the body temperature of the affected area
therefore
numbing the pain at once.
b)
The essential oils each have stimulant actions which help promote
the blood flow to the affected area.
RECOMMENDED DOSAGE/INSTRUCTION
_Adults and children 6 years of age and older:_
Apply to affected area not more than 3 to 4 times daily.
Gently massage until PERSKINDOL is absorbed. Use only as directed.
ROUTE OF ADMINISTRATION
For topical use.
CONTRAINDICATIONS
Do not apply to wounds or damaged skin. Avoid contact with eyes and
mucous membranes. Do not use when allergy reaction to one or more
essential oils is known.
WARNINGS AND PRECAUTIONS
Keep out of reach of children. For external use only. Avoid contact
with
eyes and mucous membranes. Do not use with heating pads or heating
devices. If condition worsens, skin redness or irritation develops or
if
symptoms persist for more than 7 days, discontinue use of this product
and consult a doctor. Do not apply to wounds or damaged skin. Do not
bandage tightly. If you have sensitive skin, consult a doctor before
use.
If skin irritation develops, discontinue use and consult a doctor. Do
not
use, pour, spill or store near heat or open flame.
INTERACTIONS
No known interactions.
PREGNANCY AND LACTATION
As with any drug,