WINA AQUEOUS CREAM

Country: Malaysia

Language: English

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

Active ingredient:

Cetomacrogol Emulsifying Wax; White soft paraffin; LIQUID PARAFFIN

Available from:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (International Name):

Cetomacrogol Emulsifying Wax; White soft paraffin; LIQUID PARAFFIN

Units in package:

500 gm; 100 gm

Manufactured by:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WINA AQUEOUS CREAM _ _
Cetomacrogol Emulsifying Wax/Liquid Paraffin/White Soft Paraffin
(
9.0% w/w/6.0% w/w/15.0% w/w)
WHAT IS IN THIS LEAFLET
1.
What
WINA
AQUEOUS
CREAM is used for
2.
How
WINA
AQUEOUS
CREAM works
3.
Before
you
use
WINA
AQUEOUS CREAM
4.
How to use WINA AQUEOUS
CREAM
5.
While
you
are
using
WINA
AQUEOUS CREAM
6.
Side effects
7.
Storage and disposal of WINA
AQUEOUS CREAM
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
WINA
AQUEOUS
CREAM IS USED FOR
WINA AQUEOUS CREAM is a
dermatological cream for the relief
of
the
symptoms
of
dry
skin
conditions and as soap substitute to
wash the skin.
HOW
WINA
AQUEOUS
CREAM WORKS
WINA AQUEOUS CREAM is an
emollient
cream
which
helps
soothe,
soften
and
moisture
dry
skin.
BEFORE
YOU
USE
WINA
AQUEOUS CREAM
_-When you must not use it _
This product should not be used by
individuals with known sensitivity
to any ingredients of this product.
_Pregnancy and Lactation _
You can use WINA AQUEOUS
CREAM
if
you
are
pregnant
or
breastfeeding.
_ _
_-Before you start to use it _
Please tell your doctor if you are
taking
any
other
medicines,
including herbal products or any
that you buy without a prescription
from a pharmacy, supermarket or
health food shop.
_-Taking other medicines _
Currently
there
have
been
no
reports of problems when this
product
is
used
with
other
medicines.
HOW TO USE WINA AQUEOUS
CREAM
_-How much to use _
Adults, children and elderly:
To
be
applied
to
the
skin
as
required.
_-When to use it _
Use as directed by your doctor or
pharmacist.
For use on
the skin
only
_-How long to use it _
Continue using WINA AQUEOUS
CREAM
as
your
doctor
recommended.
If
symptoms
persist, consult your doctor.
_ _
_-If you forget to use it _
Apply immediately as soon as you
remember.
_-If you use too much (overdose) _
It
is
unlikely
to
experience
overdose
if
used
as
indicated.
Contact your doctor immediately
or go to the Emergency Department
of your nearest hospital, if you or
anyone

Summary of Product characteristics

WINA AQUEOUS CREAM
COMPOSITION AND STRENGTH
Cetomacrogol Emulsifying Wax ………………………... 9.0% w/w
Liquid Paraffin …………………………………..………...
6.0% w/w
White Soft Paraffin ……………………………………...
15.0% w/w
Preservatives:
Methyl Paraben ………………………………………… 0.15%
w/w
Propyl Paraben ………………………………………… 0.08%
w/w
PRODUCT DESCRIPTION
White to off-white colour, smooth, homogeneous cream.
PHARMACODYNAMICS
White soft paraffin and liquid paraffin have emollient properties.
PHARMACOKINETICS
None applicable.
INDICATIONS
For topical application to the skin:
As an emollient for the symptomatic relief of dry skin conditions.
As a soap-substitute for skin washing.
RECOMMENDED DOSE
Adults, children and elderly:
To be applied to the skin as required.
ROUTE OF ADMINISTRATION
Topical
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
WARNINGS AND PRECAUTIONS
For external use only.
INTERACTIONS WITH OTHER MEDICAMENTS
No clinically significant drug interactions known.
PREGNANCY AND LACTATION
The safety of Aqueous Cream during pregnancy and lactation has not
been established but is not considered to constitute a hazard during
these
periods.
SIDE EFFECTS
Occasional allergic reactions.
Aqueous cream may be associated with immediate cutaneous reactions
when used as a leave-on emollient, such as stinging, burning, itching
and
redness.
OVERDOSE AND TREATMENT
An overdose is not considered likely when used as indicated.
Symptoms of accidental oral ingestion may include gastrointestinal
symptoms, particularly diarrhea. Treatment need only be symptomatic.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINE
No adverse effects known.
STORAGE CONDITIONS
Keep container tightly closed.
Store below 30ºC.
Protect from freezing, heat and direct light.
DOSAGE FORMS
Cream (Topical Semisolid)
PACK SIZE
100gm and 500 gm
REGISTRATION NUMBER
MAL15065027XZ
MANUFACTURED BY & PRODUCT REGISTRATION HOLDER
KCK PHARMACEUTICAL INDUSTRIES SDN.