Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Cetomacrogol Emulsifying Wax; White soft paraffin; LIQUID PARAFFIN
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
Cetomacrogol Emulsifying Wax; White soft paraffin; LIQUID PARAFFIN
500 gm; 100 gm
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
_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 Baca dokumen lengkap
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. Baca dokumen lengkap