Boots Antiseptic Gel

1. Name Of The Medicinal Product

Children's Antiseptic Gel

Germolene Antiseptic Gel

Boots Antiseptic Gel

2. Qualitative And Quantitative Composition

Active ingredient	%w/w
Cetylpyridinium chloride	0.025%

3. Pharmaceutical Form

Gel

4. Clinical Particulars

4.1 Therapeutic Indications

For cuts, grazes, insect bites, minor wounds, spots, minor burns and scalds.

4.2 Posology And Method Of Administration

Adults and children: Apply to the affected area two or three times a day.

For topical application.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Prolonged and repeated application is inadvisable as hypersensitivity may occur.

Do not use if the skin is weeping or badly inflamed.

Avoid contact with the eyes.

For external use only.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no clinically significant interactions.

4.6 Pregnancy And Lactation

The safety of this product during pregnancy and lactation has not been established but is not considered to constitute a hazard during these periods.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Skin irritation may occasionally occur and hypersensitivity reactions may develop in certain individuals.

4.9 Overdose

It is unlikely that systemic toxicity will result from the ingestion of this product, although it may give rise to nausea, vomiting and diarrhoea. Treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Cetylpyridinium chloride is a quaternary ammonium disinfectant having bactericidal activity against both Gram-positive and Gram-negative organisms.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Hydroxypropyl methyl cellulose

Glycerin

Sodium citrate

Anhydrous citric acid

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Laminated tube with polythene lined tamper evident seal, fitted with a PP cap or a laminate tube with polythene ionomer (Surlyn) lined tamper evident seal fitted with a PP cap or a polythene tube consisting of LLDPE and LDPE fitted with a PP cap.

Pack size: 30g

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

Trading as: BCM

8. Marketing Authorisation Number(S)

PL 00014/0556

9. Date Of First Authorisation/Renewal Of The Authorisation

29 October 1996

10. Date Of Revision Of The Text

September 2004