i-Calamine Lotion

Country: Malaysia

Language: English

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

Active ingredient:

Zinc Oxide; Calamine

Available from:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (International Name):

Zinc Oxide; Calamine

Units in package:

120 ml

Manufactured by:

IDAMAN PHARMA MANUFACTURING SDN BHD

Patient Information leaflet

I-CALAMINE LOTION
Calamine 8% w/v and Zinc Oxide 8% w/v
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What i-Calamine Lotion is used for
2. How i-Calamine Lotion works
3. Before you use i-Calamine Lotion
4. How to use i-Calamine Lotion
5. While you are using i-Calamine Lotion
6. Side effects
7. Storage and Disposal of i-Calamine
Lotion
8. Product Description
9. Manufacturer and Product Registration
Holder
10. Date of Revision
11. Serial Number
WHAT I-CALAMINE LOTION IS USED FOR
i-Calamine Lotion is a non-prescription
dermatological product.
The product is used for relief of skin
discomfort due to pruritis, mild sunburn,
insect stings and nappy rashes.
HOW I-CALAMINE LOTION WORKS
i-Calamine
Lotion
cools
the
skin
by
evaporation and it is useful in alleviating
the pain and swelling in sunburn, insect
stings, pruritis and nappy rashes.
BEFORE YOU USE I-CALAMINE LOTION
When you must not use it
Do not use i-Calamine Lotion:
If you are allergic to any of the ingredients
Before you start to use it
Tell your doctor or pharmacist if you have
any medical conditions, especially if any
of the following apply to you:
•
if you are pregnant, planning to
become pregnant, or are breast-feeding
if you are taking any prescription or
nonprescription
medicine,
herbal
preparation, or dietary supplement
•
if
you
have
allergies
to
medicines,
foods, or other substances
_Taking other medicines _
Some
medicines
may
interact
with
calamine
lotion.
However,
no
specific
interactions
with
calamine
lotion
are
known at this time.
This may not be a complete list of all
interactions
that
may occur.
Ask
your
health care provider if calamine lotion
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 I-CALAMINE LOTION
Always take i-Calamine Lotion exactly as
your
doctor
has
told
you.
Apply
the
medication to the affected area, and allow
the medication to dry on the skin.
Avoid getting this medication in the eyes,

Summary of Product characteristics

I-CALAMINE LOTION
DESCRIPTION
Pinkish red colored, smooth suspension with a strong menthol smell.
COMPOSITION
Calamine
8% w/v
Zinc Oxide
8% w/v
PRESERVATIVE:
Phenol
0.1% w/v
ALCOHOL CONTENT:
Ethyl alcohol
0.1% v/v
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
Calamine Lotion is used for the relief of skin discomfort due to
pruritis, mild sunburn, nappy
rashes, and insect stings.
RECOMMENDED DOSAGE
Apply to the affected area twice or three times daily and allowed to
dry. Repeated applications may
be administered as needed.
Shake well before use. Wash and dry affected area before each
application.
**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 any of the ingredients listed.
WARNINGS AND PRECAUTIONS
For external use only.
Avoid contacts with the eyes and other mucous membranes such as mouth,
nose and genital
region.
Not to be applied to abraded, blistered, inflamed, raw or oozing areas
of the skin.
Do not use on open wounds or burns.
Discontinue use if rash, irritation, burning sensation or sensitivity
develops/occurs.
If symptoms persist, consult your pharmacist or doctor.
PREGNANCY AND LACTATION
The safety of calamine and zinc oxide during pregnancy and lactation
has not been established
but use during these periods is not considered to constitute a hazard.
SID