ChloraPrep 2% w/v / 70% v/v impregnated cutaneous swab
chlorhexidine gluconate / isopropyl alcohol
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What ChloraPrep is and what it is used for
2. What you need to know before you use ChloraPrep
3. How to use ChloraPrep
4. Possible side effects
5. How to store ChloraPrep
6. Contents of the pack and other information
ChloraPrep is a cutaneous solution of chlorhexidine gluconate and isopropyl alcohol presented as a plastic stick with a foam pad impregnated with a fast-acting antiseptic solution on one end. The product is used to disinfect the skin and help prevent infections before invasive medical procedures.
- if you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of ChloraPrep, especially if you have a history of possible chlorhexidine-related allergic reactions (see Section 6).
- in the ear canal as the solution may damage your hearing.
ChloraPrep is for external use only.
ChloraPrep should not be used:
- near delicate linings (mucous membranes), as it may cause irritation. If it does get into the delicate linings to the body passages, it should be washed quickly with plenty of water.
- on open skin wounds.
- in direct contact with neural tissue (for example brain and spinal cord tissue).
ChloraPrep must not come into contact with the eye due to the risk of visual damage. If it comes into contact with the eyes, wash out immediately and thoroughly with water. In case of any irritation, redness or pain in the eye, or visual disturbance, ask for medical advice promptly.
Serious cases of persistent corneal injury (injury to the surface of the eye) potentially requiring corneal transplant have been reported when similar products have accidentally come in contact with the eye during surgical procedures, in patients under general anaesthesia (deep painless sleep).
ChloraPrep may in rare cases cause severe allergic reactions, leading to a drop in blood pressure and even to unconsciousness. Early symptoms of a severe allergic reaction may be skin rash or asthma. If you notice these symptoms, stop using ChloraPrep and contact your doctor as soon as possible (see under section 4: “Possible side effects”).
ChloraPrep should only be applied to the skin gently. When the solution has been applied in an over-vigorous manner to very fragile or sensitive skin or after repeated use, rash, inflammation, itching, dry and/or flaky skin and pain may occur. At the first sign of any of these reactions, applications of ChloraPrep should be stopped.
Prolonged skin contact should be avoided.
Soaked materials, such as drapes or gowns should be removed before use. The solution should not be allowed to pool.
The solution is flammable. Do not use ignition sources such as cigarettes, naked flames or strong heat source until the skin is completely dry.
Use with care in newborn babies, especially those born prematurely. ChloraPrep may cause chemical skin burns.
Tell your doctor or nurse if you have recently had a vaccine or skin test injection (patch test used to test for allergies).
There are no studies with ChloraPrep in pregnant or lactating women.
Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to chlorhexidine gluconate is negligible. ChloraPrep can be used during pregnancy.
Breast-feeding
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast- feeding woman to chlorhexidine gluconate is negligible. ChloraPrep can be used during breast- feeding.
Fertility
The effects of chlorhexidine gluconate on human reproduction have not been studied.
ChloraPrep does not affect your driving or ability to use machines.
The antiseptic solution is kept inside the aluminium pouch. Your doctor or nurse will select the ChloraPrep pouch size based on the procedure site and area to be covered. Your doctor or nurse will rub the foam pad gently over your skin, covering the skin area that needs to be prepared. Depending on your medical procedure, more than one pouch may be used.
Other ChloraPrep applicators may be more suitable, depending on the medical procedure being undertaken.
ChloraPrep is only used on the skin and each swab is only used once.
If you have any further questions on the use of this product, ask your doctor or nurse.
Like all medicines, ChloraPrep can cause side effects, although not everybody gets them.
If you experience any of the following reactions the product application should be stopped: swelling of the face, lips, tongue or throat; a red itchy skin rash; wheezing or difficulty breathing; feeling faint and dizzy; a strange metallic taste in the mouth; collapse. You may be having an allergic reaction.
If you develop a rash or your skin becomes itchy, painful, red, blistery, dry or inflamed where you have used the product, stop using ChloraPrep and talk to your doctor or pharmacist.
Very rarely (fewer than 1 in 10,000 people), allergic or irritated skin reactions to the ingredients in ChloraPrep (chlorhexidine gluconate and isopropyl alcohol) have been reported.
Other possible side effects, for which it is not known how often they occur, are: eye irritation, pain, chemical burns, corneal injury (injury to the surface of the eye), and permanent eye damage including permanent visual impairment (following accidental ocular exposure during head, face and neck surgical procedures) in patients under general anaesthesia (deep painless sleep) and skin burns in newborns/infants.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side-effects you can help provide more information on the safety of this medicine.
Flammable. Do not use with electrocautery procedures or other ignition sources until dry. Do not use while smoking or near any naked flames or strong heat source. This medicine does not require any special temperature storage conditions.
Store in the original packaging; ChloraPrep is sterile unless seal is broken.
Avoid exposure of the container and contents to naked flames during use, storage and disposal.
Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
- The active substances are chlorhexidine gluconate and isopropyl alcohol. Each swab of 1.75 ml solution contains 35 mg of chlorhexidine gluconate (20 mg/ml) and 1.23 ml isopropyl alcohol (0.70 ml/ml). Three swabs containing 5.25 ml of solution contains 105 mg of chlorhexidine gluconate (20 mg/ml) and 3.7 ml isopropyl alcohol (0.70 ml/ml).
- The other ingredient is purified water.
The ChloraPrep presentation is a plastic stick connected to an impregnated foam tip in a plastic foil containing the antiseptic solution.
The triple swabs pack contains three swabs.
Pack Size:
1.75 ml (Single swab): Carton of 48 pouches (48 swabs)
5.25 ml (Triple swabs): Carton of 40 pouches of 3 swabs (120 swabs)
Not all pack sizes may be marketed
The Marketing Authorisation holder of ChloraPrep is:
Becton Dickinson UK Ltd
1030 Eskdale Road
Winnersh
Wokingham
RG41 5TS
United Kingdom
Contact: 0800 0437 546
The Manufacturer of ChloraPrep is
Insight Health Limited
Unit A Bridgefields
Welwyn Garden City
Hertfordshire
AL7 1RX
United Kingdom
This medicinal product is authorised in the Member States of the EEA and in the United Kingdom (Northern Ireland) under the following names:
Finland - ChloraPrep
France - ChloraPrep
Germany -ChloraPrep
Ireland - ChloraPrep
Italy - ChloraPrep
Norway - Chloraprep
Portugal - Chloraprep
Sweden - Chloraprep
United Kingdom (Northern Ireland) - ChloraPrep
This leaflet was last revised in June 2024.
BD, the BD Logo, ChloraPrep are the property of Becton, Dickinson and Company or its affiliates. ©2024 BD. All rights reserved.
License Number:
PL 05920/0006