Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Salicylic acid; Methyl salicylate; Tannic acid; Boric acid
Wynlit Laboratories Ltd
D01AE20
Salicylic acid; Methyl salicylate; Tannic acid; Boric acid
8.9mg/1ml ; 5.3mg/1ml ; 48.9mg/1ml ; 31.2mg/1ml
Cutaneous paint
Cutaneous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 13100200
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phytex Paint Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Solution contains tannic acid 4.886% w/v, boric acid 3.1245 w/v, salicylates (as salicylic acid 0.89% w/v and methyl salicylate 0.526% v/v). 3 PHARMACEUTICAL FORM A clear, pale straw-coloured cutaneous solution for application to skin and nails. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of infections of the skin and nails due to superficial dermatophytes of Candida. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For adults, including the elderly, and children over five years: The tincture is painted onto the affected areas morning and evening and after washing. Several weeks of treatment may be required to prevent relapse. Children under five years: Contraindicated. 4.3 CONTRAINDICATIONS Known sensitivity to any of the ingredients. Do not use in children under five. Should not be used on broken or inflamed skin, Use in pregnancy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not use for longer than 10 days without consulting a doctor. For use on nail areas and feet only. Phytex should be used with caution in patients with impaired circulation and diabetics. Phytex is for topical use only and may be harmful if taken internally. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None stated. 4.6 FERTILITY, PREGNANCY AND LACTATION Contraindicated 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 4.8 UNDESIRABLE EFFECTS Slight stinging may occur on application. Any further discomfort caused by dryness of the skin may be due to the astringent nature of the product. 4.9 OVERDOSE Not applicable. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Borotannic complex possesses bacteriostatic and fungistatic properties. After application the solvent evaporates to leave a clear film over the infected area. Perspiration subsequently dissolves the active complex which ionises producing a low pH (about 2.0) that is Read the complete document