Hydrogen peroxide

Hydrogen Peroxide Solution 3% BP 10 Vols

Hydrogen peroxide aqueous solution 35% 7.5% v/v as the active ingredient. For a full list of excipients, see section 6.1.

Solution. A clear, colourless solution.

1. As a mild disinfectant for minor cuts, wounds and skin ulcers.2. As a mouthwash or gargle.

Topical.

Recommended dose and dosage schedule

1. As a disinfectant use as required. Dress the wound with cotton wool soaked in the peroxide.2. As a mouthwash or gargle dilute one part of the peroxide to two parts of water (e.g. 5ml of peroxide and 10ml of water). Rinse the mouth for two to three minutes. This may be repeated up to three times daily.As a disinfectant this product is suitable for use by adults, children and the elderly.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.

Hypersensitivity to any of the ingredientsNot 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.

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.

None known.

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.

None known.

Cases of gas embolism, sometimes resulting in cardiac arrest, have been reported when hydrogen peroxide has been instilled in closed body cavities or deep surgical wounds.Strong solutions of hydrogen peroxide produce irritating burns on the skin and mucous membranes with a white eschar. The pain disappears after about 1 hour. Continued use of the product as a mouthwash may cause reversible hypertrophy of the papillae of the tongue.

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.

Accidental ingestion may cause sore throat, gastric disturbances and vomiting. Sudden evolution of oxygen may cause injury by acute distension of the stomach and internal bleeding. Water may be given to drink. Ingestion of large volumes can lead to gas embolism following evolution of oxygen in the stomach.

A01A B02 – Antiinfectives and antiseptics for local oral treatment.Hydrogen peroxide is used as a disinfectant and deodorant. It releases oxygen when applied to tissues, the effect lasts only as long as the oxygen is being released and is of short duration. The antimicrobial effect of the liberated oxygen is reduced in the presence of organic matter. It is used to cleanse wounds and ulcers in concentrations of up to 6%. Adhering and blood-soaked dressings may be released by the application of a solution of hydrogen peroxide. A l.5% solution has been used as a mouthwash in the treatment of acute stomatitis and as a deodorant gargle.

No further information available.

No data of relevance which is additional to that already included in other sections of the SPC.

Concentrated Phosphoric acidPurified water

Incompatible with reducing agents including organic matter and oxidisable substances and with alkalis, iodides, permanganates and other stronger oxidising agents. Its decomposition is increased by metallic salts, light, agitation, heat and metals.

24 months unopened.

Use within 28 days of first opening

Do not store above 25°C. Store in the original container.

200ml: Round amber glass bottle with white 28mm cap with tamper evident band and EPE Saranex liner.

None.

Thornton & Ross LimitedLinthwaite LaboratoriesHuddersfieldHD7 5QH

PL 00240/5106R

21/10/2008

11/07/2022