SM CALAMINE LOTION

País: Malásia

Língua: inglês

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

Ingredientes ativos:

Calamine; Zinc Oxide

Disponível em:

SM PHARMACEUTICALS SDN. BHD.

DCI (Denominação Comum Internacional):

Calamine; Zinc Oxide

Unidades em pacote:

100ml mL; 200 ml mL; 60 ml mL; 120 ml mL

Fabricado por:

SM PHARMACEUTICALS SDN. BHD.

Características técnicas

Package Insert
Page 1 of 3
SM PHARMACEUTICALS SDN. BHD.
SM CALAMINE LOTION
DESCRIPTION:
A pink coloured viscous lotion
COMPOSITION:
Contains:
Calamine
15% w/v
Zinc Oxide
5% w/v
ACTIONS AND MODE OR MECHANISMS OF ACTION:
Calamine
Calamine has mild astringent and antipruritic actions. In addition, it
has, antiperspirant
and mild antiseptic activities. These are probably related to the
ability of the zinc ion to
precipitate protein but other mechanisms may also be involved in its
action against
bacteria.
Zinc Oxide
Zinc Oxide is mildly astringent and is used topically as a soothing
and protective
application in eczema and slight excoriations.
PHARMACOLOGY
(SUMMARY
OF
PHARMACODYNAMICS
AND
PHARMACOKINETICS):
Absorption: Calamine applied topically is not absorbed through the
skin.
INDICATIONS:
SM Calamine Lotion is indicated for the topical relief of itching,
pain, and discomfort of
minor skin irritations, such as those caused by eczemas, insect bites,
prickly heat,
sunburn and napkin rash.
CONTRAINDICATIONS:
Known hypersensitivity to any component in the formulation.
SIDE EFFECTS / ADVERSE REACTIONS:
None has been reported.
PRECAUTIONS / WARNINGS:
Pregnancy / Reproduction / Breast-feeding
Problems in humans have not been documented.
Package Insert
Page 2 of 3
DRUG INTERACTIONS:
There are no recorded cases of interactions between topical calamine
preparations and
other drugs.
RECOMMENDED
DOSAGE,
DOSAGE
SCHEDULE
AND
ROUTE
OF
ADMINISTRATION:
Wash and dry affected area. Apply sparingly to the affected parts and
surrounding skin
areas twice or three times daily.
Proper use of this medication
For external use only; keep away from eyes and other mucous membranes
such as the
mouth, nose, and anogenital region.
To apply the lotion; shake lotion well before use. Lotion should be
applied with a cotton
pledget moistened with the lotion. Then the medication should be
allowed to dry on the
skin.
Discontinue use and check with physician if condition worsens, or does
not improve
within 7 days, or if rash, irritation, or sensitivity de