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.
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4.3 Contraindications
Hypersensitivity to any of the ingredients
Contraindicated for use in closed body cavities or wounds, as a disinfection agent for surgical instruments (particularly endoscopes) and as an enema.
4.4 Special Warnings And Precautions For Use
For external use only.
Keep all medicines away from children.
Not for use on large and deep wounds.
Avoid normal skin.
Product bleaches skin.
4.5 Interaction With Other Medicinal Products 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
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.
4.9 Overdose
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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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 1.5% solution has been used as a mouthwash in the treatment of acute stomatitis and as a deodorant gargle.
5.2 Pharmacokinetic Properties
No further information available.
5.3 Preclinical Safety Data
None.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Phosphoric acid BP, phenacetin BP 1973, purified water BP.
6.2 Incompatibilities
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.
6.3 Shelf Life
150ml: 36 months unopened.
200ml: 36 months unopened.
2000ml: 36 months unopened.
6.4 Special Precautions For Storage
Store below 25°C.
Protect from light.
6.5 Nature And Contents Of Container
150ml: Round amber glass bottle with plastic cap or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.
200ml: Round amber glass bottle with plastic cap or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.
2000ml: Amber glass winchester with plastic cap or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
L.C.M. Limited
Linthwaite Laboratories
Huddersfleld
HD7 5QH
8. Marketing Authorisation Number(S)
PL 12965/0017
9. Date Of First Authorisation/Renewal Of The Authorisation
27/8/1993, 18/11/1998, 06/09/2000
10. Date Of Revision Of The Text
19/07/2010
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