Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Benzalkonium chloride; Triclosan; Light liquid paraffin
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
D08AJ; D08AJ01
Benzalkonium chloride; Triclosan; Light liquid paraffin
52.5/6/2 percent weight/weight
Bath additive
Product not subject to medical prescription
Quaternary ammonium compounds; benzalkonium
Marketed
1989-05-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oilatum Plus Bath Additive. Light liquid paraffin 52.5% w/w Benzalkonium chloride 6.0% w/w Triclosan 2.0% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Bath additive. A clear, pale yellow oily solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of infected eczemas and eczemas at risk from infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oilatum Plus should always be diluted with water. It is an effective cleanser and should not be used with soap. Bath: In an eight inch bath add 2 capfuls; in a four inch bath add 1 capful. Infant bath: Add 1 ml (just sufficient to cover the bottom of the cap) and mix well with water. Soak for 15 minutes, gently pat the skin dry with a clean towel. Use once daily. 4.3 CONTRAINDICATIONS Patients with known hypersensitivity to any of the ingredients should not use the product. Not recommended for babies younger than 6 months. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid contact of the undiluted product with the eyes. Take care to avoid slipping in the bath. Light liquid paraffin 52.5 % w/w Benzalkonium chloride 6.0 % w/w Triclosan 2.0 % w/w H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _1_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _4_ _6_ _7_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER F Læs hele dokumentet