Boots First Aid Antiseptic Liquid: Clinical Particulars
Active ingredient: cetylpyridinium chloride
- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
First Aid Antiseptic Liquid or Antiseptic Liquid.
2. Qualitative and quantitative composition
Cetylpyridinium chloride 0.025% w/v
3. Pharmaceutical form
Liquid
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of cuts, grazes, insect bites and stings, boils, spots and pimples. For the relief of symptoms of sore throats including those associated with colds and flu. For the relief of mouth infections and daily oral hygiene. For the relief of minor burns and scalds and small areas of sunburn.
4.2 Posology and method of administration
Adults, children and the elderly:
Cuts, grazes, insect bites, stings, boils, spots and pimples
Apply undiluted to the affected area
Minor burns and scalds: small areas of sunburn:
Apply undiluted to the affected area
Adults and children over 6 years and the elderly
Mouth infections and oral hygiene
Thoroughly rinse the mouth with 15ml of undiluted liquid two or three times a day. Do not swallow.
Symptoms or sore throats those associated with colds and 'flu'
Gargle two or three times a day with 15ml of undiluted liquid. Do not swallow.
4.3 Contraindications
Hypersensitivity to any of the ingredients
4.4 Special warnings and precautions for use
Use for prolonged periods should be avoided.
Use over extensive areas should be avoided.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions.
4.6 Pregnancy and lactation
There are no data to confirm the safety of the product during pregnancy and lactation, but use as recommended would not be considered to constitute a hazard.
4.7 Effects on ability to drive and use machines
No adverse effects.
4.8 Undesirable effects
Occasional irritant or hypersensitivity reactions.
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.
4.9 Overdose
In the case of ingestion, this may cause corrosive damage to the gastrointestinal tract, leading to pain, nausea, vomiting and diarrhoea. Signs of toxicity may also include euphoria, slurred speech, muscular incoordination, impairment of consciousness and coma. Treatment includes gastric aspiration and lavage. In children especially, overdosage could lead to hypoglycaemia, which should be treated with either oral or intravenous glucose.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Cetylpyridinium chloride is a cationic antiseptic with activity against both gram positive and gram negative organisms.
5.2 Pharmacokinetic properties
Not available.
5.3 Preclinical safety data
Not applicable.
6. Pharmaceutical particulars
6.1 List of excipients
Glycerol
Purified water
Alcohol 96%
Sodium citrate
Citric acid monohydrate
Methyl salicylate
Quinoline Yellow (E104)
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months
6.4 Special precautions for storage
Protect from light. Store below 30°C.
6.5 Nature and contents of container
A clear polyethylene terephthalate (PET) 150ml bottle, with a polypropylene cap having a polyethylene liner or polypropylene cap with an expanded polyethylene liner or a thermoset cap with expanded polyethylene liner.
A pigmented polyethylene terephthalate (PET) 150ml bottle with a polypropylene cap having a polyethylene liner or polypropylene cap with an expanded polyethylene liner or a thermoset cap with expanded polyethylene liner.
An amber polyethylene terephthalate (PET) 150ml bottle with a polypropylene cap having a polyethylene liner or a polypropylene cap with an expanded polyethylene liner or a thermoset cap with expanded polyethylene liner.
6.6 Special precautions for disposal and other handling
Not applicable.
7. Marketing authorisation holder
The Boots Company PLC
1 Thane Road West
Nottingham, NG2 3AA
8. Marketing authorisation number
PL 00014/0464
9. Date of first authorisation/renewal of the authorisation
23 January 1996
10. Date of revision of the text
5 February 2020