Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
ZINC OXIDE DICHLOROBENZYL ALCOHOL
Ayrton Saunders Ltd
5/0.5 %w/w
Ointment
1991-11-26
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ayrtons Antiseptic Ointment Zinc Oxide 5.0% w/w & Dichlorobenzyl Alcohol 0.5% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Smooth, soft, homogenous, pink ointment with a faint smell of methyl salicylate. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ayrtons Antiseptic Ointment is an ointment for the treatment and relief of cuts, sores, burns, wounds, rough and chapped skin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION By external application. Apply to affected parts. 4.3 CONTRAINDICATIONS Wool fat may cause local skin reactions (e.g. contact dermatitis). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Keep out of reach and sight of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None stated. 4.6 PREGNANCY AND LACTATION None stated. Zinc oxide 5.0 % w/w Dichlorobenzyl alcohol 0.5 % w/w Excipients: Wool fat 20.0 % w/w IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/12/2006_ _CRN 2030867_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 4.8 UNDESIRABLE EFFECTS None stated. 4.9 OVERDOSE Not applicable. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES 1. Zinc Oxide has a mild astringent action on the skin and acts as a soothing and protective application. 2. Dichlorobenzyl Alcohol (Myacide SP) is an antiseptic and at higher used concentrations (0.5%) has fast broad anti-microbial action. It is non-irritant even up to levels of 2.5% in ointment formulation. 5.2 PHARMACOKINETIC PROPERTIES None stated. 5.3 PRECLINICAL SAFETY DATA This product has been used over Citiți documentul complet