Colgate Peroxyl Mouthwash

Oral antiseptic mouth wash with a unique oxygenating cleaning action.

Product Details

  • HYDROGEN PEROXIDE 1.5% W/V;

    Colgate Peroxyl is an oral antiseptic mouth wash with a unique oxygenating cleansing action.

    • Helps remove debris from hard to reach areas of the mouth
    • The rapid release of oxygen has an antibacterial effect on anaerobic bacteria
    • Facilitates healing and alleviates discomfort caused by minor mouth and gum irritations, such as gum inflammation, soreness and mouth ulcers.
    PRODUCT CHARACTERISTICS
    • Rapid release of oxygen
    • Ready mixed formulation
    PRODUCT BENEFITS
    • Helps remove debris
      Antibacterial effect on anaerobic bacteria
      Alleviates discomfort
    • Increases patient compliance
      Convenient to use

      Please note this product is unavailable in Ireland

  • INDICATIONS AND USAGE

    Product indication: Minor mouth irritations.

    Product benefits: Helps mechanically debride the mouth while having an antibacterial effect on anaerobic bacteria. Ready mixed formulation makes Colgate Peroxyl convenient to use while helping to increase patient compliance.

    Mode of action: The rapid release of oxygen has an antibacterial effect on anaerobic bacteria. This facilitates healing and alleviates discomfort caused by minor mouth and gum irritations, such as gum inflammation, soreness and mouth ulcers.

     
    HOW IT WORKS

    The rapid release of oxygen helps remove debris and has an antibacterial effect on anaerobic bacteria. This facilitates healing and alleviates discomfort caused by minor mouth and gum irritations, such as aphthous ulcers, pericoronitis and trauma from fixed orthodontic braces.

     
     
    Other Colgate Products Related to Periodontal Care
  • INFORMATION
    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. CLINICAL PARTICULARS
    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)

    • Colgate Peroxyl is a medicine cabinet "must have." Soothing relief for denture irritations, cheek bites, pizza burns, orthodontic irritations, toothbrush abrasion and canker sores.

    • Colgate occasionally supplies dental professionals with samples for personal use. If you would like to try the Colgate Peroxyl mouthrinse please call 01483 401 901. Subject to availability.

    • Adults and children should rinse with 10ml (half a capful) for approximately one minute, and then spit out. It is to be used 3 times daily (after meals and at bedtime) or as directed. Children between the ages of 6-12 years old should be supervised by an adult when using Colgate Peroxyl.