Active substance(s): HYDROGEN PEROXIDE / HYDROGEN PEROXIDE / HYDROGEN PEROXIDE
NAME OF THE MEDICINAL PRODUCT
Peroxyl ™ Mouthwash.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100ml of solution contains 1.5g of Hydrogen peroxide (as 30% Hydrogen
For a full list of excipients, see section 6.1
A clear aqua-blue liquid
As a cleanser in the symptomatic relief of minor mouth and gum irritations.
Posology and method of administration
Do not use in children under the age of 6.
Peroxyl is ready to use. Rinse with 10 ml (one capful, 10 ml line within cap) 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.
Method of administration: Oromucosal use.
This medicinal product must not be used in cases of hypersensitivity of the
active substance or to any of the excipients.
Special warning and 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.
Interaction with other medicinal products and other forms of interaction
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
Effects on ability to drive and use machines
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.
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
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Peroxyl is a dilute hydrogen peroxide solution and is unlikely to cause the
symptoms of overdosage associated with strong solutions (30-40%).
Peroxyl contains levo-menthol which if accidentally ingested at excessive
amounts may cause convulsions, particularly in infants and children.
Pharmacotherapeutic group: Antiinfectives and antiseptics for local oral
ATC code: A01AB02
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.
In the mouth, salivary peroxidase breaks down hydrogen peroxide to release
water and oxygen.
Pre-clinical 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
List of excipients
Sorbitol 70%w/w (non-crystallising)
Brilliant Blue FCF (E133)
24 months (300 ml pack size)
Special Precautions for Storage
Do not store above 25°C.
Nature and contents of container
300 ml in bottle (PET), with polyethylene cap
Special precautions for disposal
No special requirements
MARKETING AUTHORISATION HOLDER
Colgate-Palmolive (UK) Ltd
Guildford Business Park
Surrey GU2 8JZ
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.