Aquasept Skin Cleanser (Molnlycke Health Care )

1. Name Of The Medicinal Product

Aquasept Skin Cleanser.

2. Qualitative And Quantitative Composition

Triclosan 2.0% w/v.

3. Pharmaceutical Form

Clear blue solution.

4. Clinical Particulars

4.1 Therapeutic Indications

This product has an antibacterial effect and is intended for the following uses: prevention of cross infection; prevention of self infection; preoperative hand disinfection; antiseptic skin cleansing; whole body bathing prior to elective surgery; whole body bathing to help eliminate the carriage of pathogens.

4.2 Posology And Method Of Administration

For preoperative hand disinfection (250 ml and 500 ml): wet area to be cleaned. Apply about 5 ml of Aquasept and wash for one minute, paying particular attention to the area around the fingernails and cuticles and between the fingers. Rinse and repeat for two minutes. Rinse thoroughly and dry hands with a sterile towel. For antiseptic skin cleansing (250 ml and 500 ml): wet area to be cleaned and use Aquasept as a liquid soap, washing thoroughly for one minute. Rinse and dry thoroughly. For whole body bathing (28.5 ml, 250 ml and 500 ml): in shower or bath, use Aquasept as a liquid soap, paying particular attention to the hair, perineum, groin, axillae and nares. Take two baths or showers on the two days prior to surgery. Approximately 28.5 ml of Aquasept will suffice for one shower or bath.

4.3 Contraindications

None.

4.4 Special Warnings And Precautions For Use

For external use only. Avoid contact with eyes. Keep out of reach of children. Some product excipients may give rise to allergic reactions in some people. In this instance, discontinue use and seek medical advice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

None stated.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

None stated.

4.9 Overdose

Ingestion: Gastric lavage and symptomatic treatment.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Triclosan is a bactericide.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified water; MEA lauryl sulphate; cocamide DEA; cocamidopropyl betaine; isopropyl alcohol; propylene glycol; tetrasodium edetate; triethanolamine; chlorocresol; Sea Fresh Perfume; Patent Blue V (E131).

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

None stated.

6.5 Nature And Contents Of Container

HDPE or HDPP container. Polypropylene wadless screwcaps or compression-moulded screw caps with steran faced pulpboard liners. Sizes: 28.5 ml, 250 ml and 500 ml.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0001.

9. Date Of First Authorisation/Renewal Of The Authorisation

3^rd July 2005.

10. Date Of Revision Of The Text

July 2005.