Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calamine; Zinc oxide; Glycerol; Bentonite; Sodium citrate; Phenol liquefied
Ennogen Healthcare Ltd
n/a
Calamine; Zinc oxide; Glycerol; Bentonite; Sodium citrate; Phenol liquefied
150mg/1ml ; 50mg/1ml ; 50mg/1ml ; 30mg/1ml ; 5mg/1ml ; 5mg/1ml
Cutaneous liquid
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13030000
CALAMINE LOTION BP Soothing protective lotion CALAMINE AND ZINC OXIDE 200ML DIRECTIONS FOR USE Liquid for topical use (application to the skin). Shake the bottle thoroughly before use. ADULTS AND CHILDREN: Apply to the affected area with cotton wool. If you accidentally swallow Sainsbury’s calamine lotion it should not cause any problems, but if you do notice anything consult your doctor or pharmacist. 6005129 11.16 R1153 Manufacturer and product licence holder: Bell, Sons & Co (Druggists) Ltd, Southport, PR9 9AL. PL03105/0011 Produced for SAINSBURY’S SUPERMARKETS LTD, LONDON EC1N 2HT. C71-0674 Ver. E Revised: 12/2016 STORAGE Do not store above 25ºC. OTHER INGREDIENTS Bentonite E558, Sodium Citrate E331, Phenol, Glycerol E442 and Purified Water. ACTIVE INGREDIENTS Calamine 15%w/v and Zinc Oxide 5%w/v. Sainsbury’s Calamine Lotion BP is applied to the skin to relieve irritation and sunburn. WARNINGS • Do not use if you are allergic to any of the ingredients with symptoms of itching, rashes or difficulty breathing. • Do not use on broken skin. • This product is safe to use if you are pregnant or breast-feeding. • FOR EXTERNAL USE ONLY. • Ask your doctor before use if having an x-ray, as the product may mask the x-ray picture. • Avoid contact with eyes, mucous membranes, and other sensitive parts of the body. • If you have an allergic reaction or notice any other side effects discontinue use and consult your doctor or pharmacist. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this label. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. 169.00 mm 65.00 mm Gloss Varnish guide Braille guide Braile reads: Sainsbury’s Calamine Lotion BP KJ32999 KSJ333282 -v2-1 23-Dec-16 Calamine Lotion 200ml AJS Cutter Guide Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calamine Lotion BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients % w/v Calamine BP 15 Zinc Oxide Ph Eur 5 3 PHARMACEUTICAL FORM Lotion 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of minor skin rashes and irritation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, children and elderly To be applied when required to the affected area. For topical application. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Shake the bottle. For external use only. Keep all medicines out of the reach of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No clinically significant interactions known. May mask x-ray pictures under certain circumstances. 4.6 FERTILITY, PREGNANCY AND LACTATION The safety of Calamine Lotion during pregnancy and lactation has not been established but used during these periods is not considered to constitute a hazard. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES No adverse effects known. 4.8 UNDESIRABLE EFFECTS Occasional hypersensitivity or irritant reactions. REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. 4.9 OVERDOSE If ingested symptoms of overdosage include anorexia, nausea, vomiting, epigastric discomfort and diarrhoea. Treatment consists of symptomatic measures only. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Calamine has a mild astringent action on the skin. 5.2 PHARMACOKINETIC PROPERTIES None known. 5.3 PRECLINICAL SAFETY DATA There are no preclinical data of relevance to the prescriber which are additional to that already included. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST O Read the complete document