Calmoseptine Ointment

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Zinc Oxide; Menthol; Lanolin; Petrolatum

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

Zinc Oxide; Menthol; Lanolin; Petrolatum

Unit dalam pakej:

20 Sachets

Dikeluarkan oleh:

Calmo Manufacturing, Inc

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
CALMOSEPTINE
_®_ OINTMENT
_ _
Zinc Oxide(20.6%), Petrolatum(24%), Lanolin(15.7%), Menthol(0.44%)
1
WHAT IS IN THIS LEAFLET
1. What Calmoseptine® Ointment is
used for
2. How Calmoseptine® Ointment
works
3. Before you use Calmoseptine®
Ointment
4. How to use Calmoseptine®
Ointment
5. While you are using it
6. Side effects
7. Storage and Disposal of
Calmoseptine® Ointment
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision.
WHAT CALMOSEPTINE® OINTMENT IS
USED FOR
The ointment is used to temporarily
protects irritated areas, temporary
relief of local itching and discomfort
in the perianal area, and for
temporary relief of pain or burning or
skin irritation.
HOW CALMOSEPTINE® OINTMENT
WORKS
The ointment works as moisture
barrier and astringent.
BEFORE YOU USE CALMOSEPTINE®
OINTMENT
-_When you can’t use the product _
If you experience any allergy to the
ingredients listed.
_- Before you start to use it _
Cleanse the affected area with mild
soap and warm water and rinse
thoroughly. Gently pat or air before
application of this product.
_- Taking other medicines _
None known interaction with other
medicines.
HOW TO USE CALMOSEPTINE®
OINTMENT
_- How much to use _
Adult: Apply externally to the
affected area up to 6 times daily
Children under 12 years of age:
Consult doctor before use.
_- When to use it _
Use up to 6 times or after each bowel
movement.
_- How long to use it _
Apply until symptom resolve. If the
condition does not improve within 7
days, seek doctor’s attention.
_- If you forget to use it _
Apply as necessary when it is
required.
_- If you use too much (overdose) _
In case of accidental ingestion, call
Poison Control Center immediately.
WHILE YOU ARE USING IT
_- Things you must do _
When practical, cleanse the affected
area with mild soap and warm water
and rinse thoroughly. Gently pat dry
or air dry before application of this
product. Apply externally to the
affected area up to 6 times daily or
after e

Ciri produk

CALMOSEPTINE
®
OINTMENT PACKAGE INSERT
1.
PRODUCT NAME:
Calmoseptine® Ointment
2.
NAME AND STRENGTH OF ACTIVE INGREDIENTS:
1).
Lanolin 15.7%
2).
Menthol 0.44%
3).
Petrolatum 24%
4).
Zinc Oxide 20.6 %
3.
PRODUCT DESCRIPTION:
Calmoseptine® Ointment has a smooth, thick, light pink appearance and
a mild menthol smell.
4.
PHARMACODYNAMICS:
_Lanolin_ is an emollient; it softens the skin by forming an occlusive
oil film on the stratum corneum, thus
decreasing the trans‐epidermal water loss. Lanolin forms a temporary
barrier over exposed tissues,
maintaining moisture and protecting from external irritants.
_Menthol_ serves to produce a counterirritant effect through sensory
stimulation. It also provides a cooling
effect through stimulation of cold receptors.
_Petrolatum_ is a moisturizer that prevents water evaporation from the
surface of the skin by creating an
oily layer on the skin surface. Petrolatum also has water repelling
properties which acts as a
temporary skin barrier.
_Zinc Oxide_ is a skin protectant / astringent with antimicrobial
properties which tends to shrink or
constrict body tissues locally after topically applying to the skin.
PHARMACOKINETICS:
The active ingredients exert their therapeutic effect without being
absorbed into the systemic
circulation.
5.
INDICATION:
Calmoseptine® Ointment temporarily protects irritated areas for the
temporary relief of local itching and
discomfort in the perianal area and for temporary relief of pain or
burning and skin irritations.
6.
RECOMMENDED DOSE:
Adults: When practical, cleanse the affected area with mild soap and
warm water and rinse thoroughly.
Gently pat dry or air dry before application of this product. Apply
externally to the affected area up to 6
times daily or after each bowel movement.
Children under 12 years of age: consult a doctor.
7.
MODE OF ADMINISTRATION:
Applied topically on the affected area.
CALMOSEPTINE® OINTMENT PACKAGE INSERT
8.
CONTRAINDICATION:
Hypersensitivity to the active substance(s) or to any of the
excipients listed. Certain pe