Страна: Мальта
Язык: английский
Источник: Medicines Authority
HYDROGEN PEROXIDE
LCM Limited Linthwaite Laboratories, Huddersfield, HD7 5QH, United Kingdom
D08AX01
HYDROGEN PEROXIDE 22.5 % (V/V)
SOLUTION
HYDROGEN PEROXIDE 22.5 % (V/V)
OTC
ANTISEPTICS AND DISINFECTANTS
Withdrawn
2006-10-31
CARRIER: FRONT FACE: FRONT FACE REVERSE: 65MM X 170MM MULTIPEEL WITH 50MM HINGE LEFT PRINT LAYOUT DIAGRAM MHRA HEADER BOX PRODUCT TITLE COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE COLOURS USED FONTS USED Landscape peelable label 200ml 23744009 65 x 170mm 1 19.09.2017 Hydrogen Peroxide Solution 9% 30 vols Helvetica Helvetica Neue Univers Optima BQ 7pt 6.6pt 9.5pt 12pt 9pt 15pt 9.5pt 12pt Process Cyan Process Magenta Process Yellow Process Black Keyline (Non-Printing) Braille Text Free Area (Non-Printing) POINT SIZES USED MIN MAX _HYDROGEN_ _PEROXIDE_ _SOLUTION 9%_ _30 VOLS_ FOR EXTERNAL USE ONLY FOR USE AS A MILD SKIN DISINFECTANT, MOUTHWASH OR GARGLE 200ML PEEL HERE IMPORTANT: PEEL THIS LABEL AT CORNER AND READ BEFORE USE. DO NOT TEAR OFF, RE-FIX FOR FUTURE USE. For use as a mild disinfectant for minor cuts, wounds and skin ulcers or as a mouthwash and gargle. FOR SKIN DISINFECTION: ADULTS, THE ELDERLY AND CHILDREN: • Dilute a portion of the peroxide with an equal amount of water. • Soak some cotton wool in this solution and use it to dress the wound as required. AS A MOUTHWASH OR GARGLE: ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS: • Dilute a portion of the peroxide with eight times the amount of water e.g. 5ml of peroxide and 40ml of water. • Use this solution to rinse the mouth for 2 – 3 minutes. • Repeat up to three times a day. DO NOT GIVE TO CHILDREN UNDER 12 YEARS OLD AS A MOUTHWASH unless your doctor tells you to. PEEL WHERE SHOWN FOR FURTHER PRECAUTIONS. ACTIVE INGREDIENT: hydrogen peroxide 9% w/v. ALSO CONTAINS: phosphoric acid (E338), phenacetin and purified water. Do not store above 25°C. Protect from light. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Manufactured by the licence holder L.C.M. Ltd., Huddersfield, HD7 5QH, UK for Thornton and Ross Ltd., Huddersfield, HD7 5QH, UK. MA213/00702 PL 12965/0017 PIP: 108-6677 23744009 This medicine contains hydrogen peroxide, a disinfectant and deodorant. It kills bacteria by releasing oxygen when in contact with body tissues. 1. BEF Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrogen Peroxide Solution 9% 30 Vols 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrogen peroxide aqueous solution 35% w/w HSE 22.5% v/v. 3 PHARMACEUTICAL FORM Solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. As a mild disinfectant for minor cuts, wounds and skin ulcers. 2. As a mouthwash or gargle. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Topical. 1. As a disinfectant: Use as required. Dress the wound with cotton wool soaked in a solution of equal parts of peroxide and water. As a disinfectant this product is suitable for use by adults, children and the elderly. 2. As a mouthwash or gargle: Dilute one part of peroxide to eight parts of water. Rinse the mouth for two to three minutes. This may be repeated up to three times daily. As a mouthwash or gargle the product is suitable for use by adults, children over 12 years and the elderly. Due to the risk of swallowing it should only be used by younger children under the instruction of a doctor. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients Not for use in closed body cavities or on surgical wounds due to the risk of oxygen released into the circulation causing gas embolism. Not for use as a disinfection agent for surgical instruments (particularly endoscopes) and as an enema. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE For external use only. Keep all medicines away from children. Not for use in closed body cavities or on surgical wounds due to risk of oxygen released into the circulation causing gas embolism. Avoid normal skin. Product bleaches fabric. 4.5 INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION All medicines should be avoided if possible during pregnancy and lactation. No evidence is available as to the safety of use of this product in these conditions. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS Cases of gas embolism, sometimes resulting in cardiac Прочитать полный документ