Tuesday, October 25, 2016

Calamine Lotion BP





1. Name Of The Medicinal Product



Calamine Lotion BP


2. Qualitative And Quantitative Composition









 
 


Calamine BP




15.0% w/v




Zinc Oxide BP




5.0% w/v



3. Pharmaceutical Form



Lotion



4. Clinical Particulars



4.1 Therapeutic Indications



For relief of the symptoms of mild sunburn and other minor skin conditions.



4.2 Posology And Method Of Administration



Topical. Applied directly to the skin.



Recommended dose and dosage schedule



The product is suitable for use by adults, children and the elderly.



Apply gently with a pad of cotton wool to the affected parts as required.



4.3 Contraindications



None known.



4.4 Special Warnings And Precautions For Use



Shake the bottle.



For external use only.



Keep all medicines away from children



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



May mask x-ray pictures under certain circumstances.



4.6 Pregnancy And Lactation



No evidence has been found as to the safety of the product when used during pregnancy and lactation. However, the product has been used for many years without any apparent ill effects.



4.7 Effects On Ability To Drive And Use Machines



None known.



4.8 Undesirable Effects



None known



4.9 Overdose



Overdose is considered unlikely with this product. However, if large quantities have been ingested, vomiting, inflammation of mucous membranes of the mouth and stomach, weakness, mental confusion, cold sweats, depression of pulse and leg cramps may occur.



Where phenol has been swallowed it may be necessary to empty the stomach by aspiration and lavage. Castor oil or olive oil may be added to the water to dissolve the phenol and delay absorption: 50ml of oil may be left in the stomach.



The patient should be kept warm, and pulmonary oedema, systemic acidosis, respiratory failure and circulatory failure should be treated symptomatically. Respiration may have to be assisted.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Calamine has a mild astringent action of the skin and is used as a dusting powder, cream, lotion or ointment in a variety of skin conditions.



Zinc oxide has a mildly antiseptic action and is a mild astringent, it has soothing and protective properties.



5.2 Pharmacokinetic Properties



No information available.



5.3 Preclinical Safety Data



None.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Bentonite BP, sodium citrate BP, glycerol BP, phenol BP and purified water BP.



6.2 Incompatibilities



None known.



6.3 Shelf Life









 
 


100ml:




36 months unopened




200ml:




36 months unopened



6.4 Special Precautions For Storage



Store below 25°C.



6.5 Nature And Contents Of Container








100ml:




Glass bottle with polypropylene cap or white 28mm cap with tamper evident band and EPE Saranex liner




200ml:




Glass bottle with polypropylene cap or white 28mm cap with tamper evident band and EPE Saranex liner



6.6 Special Precautions For Disposal And Other Handling



None.



7. Marketing Authorisation Holder



L.C.M. Ltd.,



Linthwaite Laboratories,



Huddersfield,



HD7 5QH,



England.



8. Marketing Authorisation Number(S)



PL 12965/0003



9. Date Of First Authorisation/Renewal Of The Authorisation



25/8/1993 / 22/10/1998, 15/12/2000



10. Date Of Revision Of The Text



10/09/2010



11 DOSIMETRY (IF APPLICABLE)


Not Applicable



12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)


Not Applicable




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