Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Calamine; Zinc Oxide
IDAMAN PHARMA MANUFACTURING SDN BHD
Calamine; Zinc Oxide
30 gm
IDAMAN PHARMA MANUFACTURING SDN BHD
_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 Прочитайте повний документ
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 Прочитайте повний документ