IDAMAN PHARMA CALAMINE CREAM

Country: Malaysia

Language: English

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

Active ingredient:

Calamine; Zinc Oxide

Available from:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (International Name):

Calamine; Zinc Oxide

Units in package:

30 gm

Manufactured by:

IDAMAN PHARMA MANUFACTURING SDN BHD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
IDAMAN PHARMA CALAMINE CREAM
Calamine/ Zinc Oxide (8% w/w / 3% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Calamine Cream is used for
2.
How Calamine Cream works
3.
Before you use Calamine Cream
4.
How to use Calamine Cream
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Calamine
Cream
8.
Product Description
9.
Product
Registration
Holder
and Manufacturer
10.
Date of Revision
WHAT CALAMINE CREAM IS USED FOR
Calamine
Cream
is
a
non-prescription
skin product.
The product is used for the relief of
itching, pain and discomfort due to minor
skin
irritations,
such
eczemas,
insect
bites/stings or other minor skin irritation
and relief of itchiness in Chickenpox viral
infection.
HOW CALAMINE CREAM WORKS
Calamine Cream produces a cooling effect
to the skin and it is useful in alleviating
the skin irritation, itchiness and pain.
BEFORE YOU USE CALAMINE
CREAM
-
_When you must not use it_
If you are allergic to Calamine, Zinc
Oxide and any of the ingredients at the
end of this leaflet.
-
_Before you start to use it_
Do not use on open wounds or burn and
not to be applied to abraded, blistered,
raw or oozing areas of the skin.
_PREGNANCY AND LACTATION_
Your doctor or pharmacist will advise
you
if
you
can
use
Calamine
Cream
during pregnancy or while you are
breast-feeding.
However,
use
of
Calamine
Cream
not
considered to constitute a hazard.
_-_
_ _
_Taking other medicines_
Some
medicines
may
interact
with
Calamine Cream. However, no specific
interactions
with
Calamine
Cream
are
known at this time.
Calamine
Cream
may
mask
x-ray
pictures under certain circumstances.
Ask
your
health
care
provider
if
Calamine Cream may
interact
with
other medicines
that you take. Check
with your health care provider before
you start, stop, or change the dose of any
medicine.
HOW TO USE CALAMINE
CREAM
Always
use Calamine Cream exactly
as
your doctor has told you.
Avoid getting this medication in the eyes,
mouth, nose and genital region. Please
ensure the cap seal is not broken befor

Summary of Product characteristics

IDAMAN PHARMA CALAMINE CREAM
DESCRIPTION
Clean, soft, homogenous cream. Colour pink.
Odor: Of perfume.
COMPOSITION
This cream contains:
Calamine : 8% w/w
Zinc Oxide : 3% w/w
Preservative:
Chlorocresol: 0.1% w/w
Phenyl Ethyl Alcohol: 0.407% w/w
PHARMACODYNAMICS
Calamine has mild astringent and antipruritic actions on the skin and
is
used to relieve the discomfort of dermatitis as it produces a cooling
effect
and helps to divert attention away from the itching and thus giving
relief
from skin irritations. Zinc Oxide is applied externally as a mild
astringent
for the skin. Zinc Oxide has soothing and protective properties and is
used in topical preparations for eczema, slight excoriations, wounds
and
haemorrhoids. It also reflects ultraviolet radiation and can be used
as a
physical sunscreen.
PHARMACOKINETICS
Absorption:
Calamine and Zinc Oxide are not absorbed through the skin.
INDICATIONS
Indicated for the topical soothing relief of itching, pain, and
discomfort
due to minor skin irritations, such as those caused by eczemas, insect
bites, insect stings, prickly heat, sunburn, napkin rash, cosmetic
rashes,
pruritis of dry skin including as well as symptomatic relief of
itchiness in
Chickenpox viral infection.
RECOMMENDED DOSE
Wash and dry affected area before each application.
Apply sparingly to the affected parts and surrounding skin areas twice
or
three times daily.
Repeated applications may be administered as needed.
**Extremes of temperature, wearing tight fitting nappies or
non-breathable
clothing such as polyester or nylon can make itching worse.
ROUTE OF ADMINISTRATION
Topical
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipient.
WARNINGS & PRECAUTIONS
• For external use only.
• Not to be taken.
• Avoid contact with the eyes and other mucous membranes such as
mouth, nose and genital region.
• Not to be applied to abraded, blistered, raw or oozing areas of
the skin.
• Do not use on open wounds or burns.
• Discontinue use if rash, irritation, burning sensation or
se