Boots First Aid Antiseptic Liquid

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.

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

24 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(S)

PL 00014/0464

9. Date Of First Authorisation/Renewal Of The Authorisation

23 January 1996

10. Date Of Revision Of The Text

October 2009