1. Name Of The Medicinal Product
Peroxyl™ Mouthwash.
2. Qualitative And Quantitative Composition
100ml of solution contains 1.5g of Hydrogen peroxide (as 35% Hydrogen Peroxide solution).
For excipients, see 6.1
3. Pharmaceutical Form
Mouthwash
A clear aqua-blue liquid
4.1 Therapeutic Indications
As a cleanser in the symptomatic relief of minor mouth and gum irritations.
4.2 Posology and Method of Administration
Oromucosal use.
Peroxyl is ready to use. Rinse with 10 ml (half a capful) for approximately one minute, then spit out. Use 3 times daily (after meals and at bedtime) or as directed by a doctor or dentist.
Adults and children over 12 years: as above.
Children between 6 - 12 years old: Use under the supervision of an adult.
The duration of the treatment should not exceed 7 days.
4.3 Contraindications
Hypersensitivity to the active ingredient or other compounds in the preparation.
Do not use in children under the age of 6.
4.4 Special Warnings and Special Precautions for Use
Do not swallow.
If irritation persists for 7 days, is severe, is due to orthodontic appliances and/or dentures, or swelling or fever develops, the patient's condition needs to be re-evaluated by a doctor or dentist.
Overdose can injure the gums and continued use of hydrogen peroxide may cause reversible hypertrophy of the papillae of the tongue known as 'black hairy tongue' therefore using this product at high doses or for long periods of time is not recommended.
Avoid contact with eyes.
4.5 Interactions with other Medicinal Products and other Forms of Interaction
Not applicable.
4.6 Pregnancy and Lactation
Although there are not sufficient specific clinical data on the use of Peroxyl in this patient group, self-administration without medical advice is not recommended.
4.7 Effects on Ability to Drive and Use Machines
Not applicable
4.8 Undesirable Effects
Some cases of mucosal irritation and swelling of the oral tissues have been reported specially with high doses or in continued use (see special warnings, above). The symptoms will resolve on stopping treatment with Peroxyl.
4.9 Overdose
Peroxyl is a dilute hydrogen peroxide solution and is unlikely to cause the symptoms of overdosage associated with strong solutions (30-40%).
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Hydrogen peroxide is an oral antiseptic cleanser. The principal action is brought about by contact of hydrogen peroxide with peroxidases and catalases present in tissues and saliva, which causes the rapid release of oxygen. This provides mechanical cleansing which flushes out mouth debris, and helps in the treatment of oral irritations.
5.2 Pharmacokinetic Properties
In the mouth, salivary peroxidase breaks down hydrogen peroxide to release water and oxygen.
5.3. Preclinical Safety Data
Low doses of hydrogen peroxide do not produce tissue damage or result in neoplastic changes. Application of Peroxyl to abraded mucosa in the hamster cheek pouch study over 21 days showed no adverse effect.
Hydrogen peroxide is not genotoxic in animals. The available data on reproductive toxicology are incomplete but do not indicate an effect at low concentrations.
6. Pharmaceutical Particulars
6.1 List of Excipients
Purified Water
Sorbitol 70%w/w (non-crystallising)
Ethanol 96%
Poloxamer F108
Polysorbate 20
Methyl salicylate
Levo-Menthol
Sodium saccharin
Brilliant Blue FCF (E133)
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
24 months (300 ml pack size)
18 months (50 ml pack size)
6.4 Special Precautions for Storage
Do not store above 25°C.
6.5 Nature and Content of Container
50 ml in bottle (PE), with polypropylene cap
300 ml in bottle (PE), child resistant closure with polypropylene cap
6.6 Instruction for Use and Handling
No special requirements
7. Marketing Authorisation Holder
Colgate-Palmolive (UK) Ltd
Guildford Business Park
Middleton Road
Guildford
Surrey GU2 8JZ
UK
8. Marketing Authorization Number(s)
PL 00049/0038
9. Date Of First Authorization/Renewal Of Authorization
Date of first authorisation: 29 November 1996
Date of last renewal: 29 November 2001
10. Date Of Revision Of The Text
May 2006
11. Legal Classification
GSL
12. Manufacturers Recommended Retail Price
£3.99 (300ml bottle)
