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LEAFLET

PRODUCT LEAFLET: INFORMATION FOR THE USER AQUASEPT SKIN CLEANSER 2% w/v Triclosan

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Aquasept Skin Cleanser carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    If any the side effects become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Aquasept Skin Cleansers is and what it is used for.

2.    Before you use Aquasept Skin Cleanser.

3.    How to use Aquasept Skin Cleanser.

4.    Possible side effects.

5.    How to store Aquasept Skin Cleanser.

6.    Further information.

1. WHAT AQUASEPT SKIN CLEANSER IS AND WHAT IT IS USED FOR

Aquasept Skin Cleanser is a water-based, clear blue cutaneous solution (i.e for use on the skin) containing 2% w/v Triclosan, which has antiseptic properties (it kills many types of germs).

Aquasept Skin Cleanser is used for: prevention of cross-infection; prevention of self-infection; pre-operative hand disinfection; antiseptic skin cleansing; whole body bathing before surgery; whole body bathing to help eliminate any pathogens (germs) being carried on the skin.

2. BEFORE YOU USE AQUASEPT SKIN CLEANSER Do not use Aquasept Skin Cleanser

- if you are allergic (hypersensitive) to Triclosan or any of the other ingredients listed in section 6 of this leaflet.

Take special care when using Aquasept Skin Cleanser

Avoid contact with the eyes.

Using other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Pregnancy and breastfeeding

There are no known reasons for not using Aquasept Skin Cleanser whilst pregnant or breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Effects on ability to drive or use machinery

Aquasept Skin Cleanser should not affect your ability to drive or operate machinery.

Important information about some of the ingredients of Aquasept Skin Cleanser

Propylene glycol may cause skin irritation. Chlorocresol may cause allergic reactions.

3. HOW TO USE AQUASEPT SKIN CLEANSER

For external use only (on the skin). Always use Aquasept Skin Cleanser exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is as follows:

For hand disinfection before surgery: Wet the area to be cleansed. Apply about 5ml 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: Wet area to be cleansed and use Aquasept as a liquid soap, washing thoroughly for one minute. Rinse and dry thoroughly.

For Whole body bathing: In shower or bath, use Aquasept as a liquid soap, paying particular attention to the hair, the area between the upper legs (the perineum), groin, armpits and nostrils. Take two baths or showers on the two days before the surgery. About 28.5ml of Aquasept will be enough for one shower or bath.

If you swallow Aquasept Skin Cleanser: Seek medical advice, taking this leaflet with you. Ingestion can be treated with gastric lavage (washing-out the stomach) and providing general medical support including monitoring renal and liver function, electrolytes and blood acetone levels.

4. POSSIBLE SIDE EFFECTS

Like all medicine, Aquasept Skin Cleanser can cause side effects, although not everyone gets them.

Some ingredients may give rise to allergic reactions or skin irritation. If this happens, stop using the product and speak to your doctor or pharmacist.

If any skin reactions become serious or if you notice any other side effects, please tell your doctor or pharmacist.

5.    HOW TO STORE AQUASEPT SKIN CLEANSER

Keep out of the reach and sight of children.

Do not use after the expiry date shown on the label.

The expiry date refers to the last date of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Aquasept Skin Cleanser contains:

-    The active substance is Triclosan 2% w/v (each ml of Aquasept Skin Cleanser contains 20mg of Triclosan).

-    The other ingredients are : Purified water, MEA lauryl sulphate, cocamide

DEA, cocamidopropyl betaine, isopropyl alcohol, propylene glycol (E1520), tetrasodium EDTA, triethanolamine, chlorocresol, sea fresh perfume, patent blue V (E131).

What Aquasept Skin Cleanser looks like and contents of the pack:

Aquasept Skin Cleanser is a blue-coloured solution, with a fresh smelling perfume. It is presented in white plastic bottles containing either 250ml or 500ml of the product. No all pack sizes may be marketed.

Marketing Authorisation Holder: Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire WA7 1NU, UK

Manufacturer:

This text was last updated October 2012

Label:

AQUASEPT SKIN CLEANSER 2% w/v Triclosan

A bactericidal skin cleansing solution for hand disinfection prior to surgery and for routine skin cleansing to reduce the risk of cross-infection

AVOID CONTACT WITH EYES.

FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

IF SWALLOWED SEEK URGENT MEDICAL ADVICE.

Stock No:

500ml

Manufacturer:

AYRTON SAUNDERS LTD LOGO

Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU, UK.

Preoperative hand disinfectant:

Wet area to be cleansed. Apply about 5ml 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:

Wet area to be cleansed and use Aquasept as a liquid soap, washing thoroughly for one minute. Rinse and dry thoroughly.

For Whole body bathing:

In shower or bath, use Aquasept as a liquid soap, paying particular attention to the hair, the area between the upper legs (the perineum), groin, armpits and nostrils. Take two baths or showers on the two days before the surgery. About 28.5ml of Aquasept will be enough for one shower or bath.

Also contains:

Purified Water, MEA Lauryl Sulphate, Cocamide DEA, Cocamidopropyl Betaine, Isopropyl Alcohol, Propylene Glycol (E1520) , Tetrasodium EDTA, Triethanolamine, Chlorocresol, Sea Fresh Perfume, Patent Blue V (E131).

Warning:

Contains Propylene glycol: may cause skin irritation.

Contains Chlorocresol: may cause allergic reactions.

Please report any adverse reactions to this product to the doctor or pharmacist. This product has a 3 year shelf life from manufacture.

Do not use after the expiry date.

Text revised: October 2012

Aquasept is a trademark

MA Holder: Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire WA7 1NU, UK

PL16431/0199

LEAFLET

PRODUCT LEAFLET: INFORMATION FOR THE USER AQUASEPT SKIN CLEANSER 2% w/v Triclosan

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Aquasept Skin Cleanser carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    If any the side effects become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Aquasept Skin Cleansers is and what it is used for.

2.    Before you use Aquasept Skin Cleanser.

3.    How to use Aquasept Skin Cleanser.

4.    Possible side effects.

5.    How to store Aquasept Skin Cleanser.

6.    Further information.

1. WHAT AQUASEPT SKIN CLEANSER IS AND WHAT IT IS USED FOR

Aquasept Skin Cleanser is a water-based, clear blue cutaneous solution (i.e for use on the skin) containing 2% w/v Triclosan, which has antiseptic properties (it kills many types of germs).

Aquasept Skin Cleanser is used for: prevention of cross-infection; prevention of self-infection; pre-operative hand disinfection; antiseptic skin cleansing; whole body bathing before surgery; whole body bathing to help eliminate any pathogens (germs) being carried on the skin.

2. BEFORE YOU USE AQUASEPT SKIN CLEANSER Do not use Aquasept Skin Cleanser

- if you are allergic (hypersensitive) to Triclosan or any of the other ingredients listed in section 6 of this leaflet.

Take special care when using Aquasept Skin Cleanser

Avoid contact with the eyes.

Using other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Pregnancy and breastfeeding

There are no known reasons for not using Aquasept Skin Cleanser whilst pregnant or breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Effects on ability to drive or use machinery

Aquasept Skin Cleanser should not affect your ability to drive or operate machinery.

Important information about some of the ingredients of Aquasept Skin Cleanser

Propylene glycol may cause skin irritation. Chlorocresol may cause allergic reactions.

3. HOW TO USE AQUASEPT SKIN CLEANSER

For external use only (on the skin). Always use Aquasept Skin Cleanser exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is as follows:

For hand disinfection before surgery: Wet the area to be cleansed. Apply about 5ml 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: Wet area to be cleansed and use Aquasept as a liquid soap, washing thoroughly for one minute. Rinse and dry thoroughly.

For Whole body bathing: In shower or bath, use Aquasept as a liquid soap, paying particular attention to the hair, the area between the upper legs (the perineum), groin, armpits and nostrils. Take two baths or showers on the two days before the surgery. About 28.5ml of Aquasept will be enough for one shower or bath.

If you swallow Aquasept Skin Cleanser: Seek medical advice, taking this leaflet with you. Ingestion can be treated with gastric lavage (washing-out the stomach) and providing general medical support including monitoring renal and liver function, electrolytes and blood acetone levels.

4. POSSIBLE SIDE EFFECTS

Like all medicine, Aquasept Skin Cleanser can cause side effects, although not everyone gets them.

Some ingredients may give rise to allergic reactions or skin irritation. If this happens, stop using the product and speak to your doctor or pharmacist.

If any skin reactions become serious or if you notice any other side effects, please tell your doctor or pharmacist.

5.    HOW TO STORE AQUASEPT SKIN CLEANSER

Keep out of the reach and sight of children.

Do not use after the expiry date shown on the label.

The expiry date refers to the last date of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Aquasept Skin Cleanser contains:

-    The active substance is Triclosan 2% w/v (each ml of Aquasept Skin Cleanser contains 20mg of Triclosan).

-    The other ingredients are : Purified water, MEA lauryl sulphate, cocamide

DEA, cocamidopropyl betaine, isopropyl alcohol, propylene glycol (E1520), tetrasodium EDTA, triethanolamine, chlorocresol, sea fresh perfume, patent blue V (E131).

What Aquasept Skin Cleanser looks like and contents of the pack:

Aquasept Skin Cleanser is a blue-coloured solution, with a fresh smelling perfume. It is presented in white plastic bottles containing either 250ml or 500ml of the product. No all pack sizes may be marketed.

Marketing Authorisation Holder: Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire WA7 1NU, UK

Manufacturer:

This text was last updated October 2012