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ChloraPrep with Tint

Active Ingredient:
chlorhexidine gluconate , isopropyl alcohol
Company:  
Becton Dickinson U.K Limited See contact details
ATC code: 
D08AC52
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About Medicine
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Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 08 Sep 2025
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 05920/0003.

{printer} Print patient leaflet as text only

ChloraPrep with Tint

Package leaflet: Information for the user

ChloraPrep with Tint 2% w/v / 70% v/v

Cutaneous Solution

Chlorhexidine Gluconate / Isopropyl Alcohol

3 ml / 10.5 ml / 26 ml

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
  • 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 with Tint is and what it is used for
2. What you need to know before you use ChloraPrep with Tint
3. How to use ChloraPrep with Tint
4. Possible side effects
5. How to store ChloraPrep with Tint
6. Contents of the pack and other information

1. What ChloraPrep with Tint is and what it is used for

ChloraPrep with Tint is a cutaneous solution of chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v in a plastic applicator with a sponge tip on one end. The applicator contains a fast acting antiseptic solution, which is used to disinfect the skin and help prevent infections before invasive medical procedures, such as injections, insertion of catheters and minor or major surgery. ChloraPrep with Tint contains a tint to colour the skin, which plays no role in the antiseptic properties of the solution.

2. What you need to know before you use ChloraPrep with Tint
Do not use ChloraPrep with Tint:
  • if you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of ChloraPrep with Tint, especially if you have a history of possible chlorhexidine-related allergic reactions (see Section 6).

Warnings and precautions

ChloraPrep with Tint is for external use only.

ChloraPrep with Tint should not be used:

  • near delicate linings (mucous membranes), as it may cause irritation. If it does get into or the delicate linings to the body passages, it should be washed quickly with plenty of water.
  • on open skin wounds.
  • on the part of the ear that is inside the body (middle ear).
  • in direct contact with neural tissue (for example brain and spinal cord tissue).

ChloraPrep with Tint 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 with Tint 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 with Tint and contact your doctor as soon as possible (see under section 4: “Possible side effects”).

ChloraPrep with Tint 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, application of ChloraPrep with Tint 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 until the skin is completely dry.

Children

Use with care in newborn babies, especially those born prematurely. ChloraPrep with Tint may cause chemical skin burns.

Other medicines and ChloraPrep with Tint

Tell your doctor or nurse if you have recently had a vaccine or skin test injection (patch test used to test for allergies).

Pregnancy, breast-feeding and fertility

There are no studies with ChloraPrep with Tint in pregnant or lactating women.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to chlorhexidine gluconate is negligible. ChloraPrep with Tint can be used during pregnancy.

Lactation

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to chlorhexidine gluconate is negligible. ChloraPrep with Tint can be used during breast-feeding.

Fertility

The effects of chlorhexidine gluconate on human reproduction have not been studied.

Driving and using machines

ChloraPrep with Tint does not affect your driving or ability to use machines.

3. How to use ChloraPrep with Tint

The antiseptic solution within the ChloraPrep with Tint system is kept inside the plastic applicator. Your doctor or nurse will select the applicator size based on the procedure site and area to be covered. Your doctor or nurse will rub the sponge gently over your skin, covering the skin area that needs to be prepared. Depending on your medical procedure, more than one applicator may be used.

ChloraPrep with Tint is only used on the skin and each applicator is only used once.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, ChloraPrep with Tint can cause side effects, although not everybody gets them.

If you experience any of the following reactions stop using ChloraPrep with Tint and get immediate medical help: 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 as a skin wash, stop using ChloraPrep with Tint 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 with Tint (chlorhexidine gluconate, isopropyl alcohol and the tint Sunset Yellow E110) have been reported.

Other possible side effects, for which it is not known how often they occur, are: eye irritation, pain, 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), chemical burns, and skin burns in newborns/infants.

Reporting of side effects

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.

5. How to store ChloraPrep with Tint

Flammable. This medicine does not require any special temperature storage conditions.

Store in the original packaging; applicator 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.

6. Contents of the pack and other information
What ChloraPrep with Tint contains
  • The active substances are chlorhexidine gluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml.
  • The other ingredients are purified water and Sunset Yellow (E110).

What ChloraPrep with Tint looks like and contents of the pack

The 3 ml and 10.5 ml applicators consist of a latex-free round foam sponge attached to a plastic barrel which holds a glass ampoule containing the antiseptic solution. The 26 ml applicator consists of a latex-free square foam sponge attached to a plastic barrel which holds two glass ampoules containing the antiseptic solution. The sterile applicators are individually packaged in a transparent film.

Pack Size:

3 ml: 1 applicator or 25 applicators

10.5 ml: 1 applicator or 25 applicators

26 ml: 1 applicator

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder of ChloraPrep with Tint is

Becton Dickinson UK Ltd
1030 Eskdale Road
Winnersh
Wokingham
RG41 5TS
United Kingdom
Telephone: 0800 0437 546

The Manufacturer of ChloraPrep with Tint 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 under the following names:

Austria - Chloraprep gefärbt

Belgium - Getinte ChloraPrep, ChloraPrep coloré, Chloraprep gefärbt

Finland - ChloraPrep värillinen

France - ChloraPrep coloré

Germany - Chloraprep gefärbt

Ireland - ChloraPrep with Tint

Italy - ChloraPrep con Colorante

Luxembourg - ChloraPrep coloré

Malta - ChloraPrep with Tint

Netherlands - Getinte ChloraPrep

Norway - Chloraprep med farge

Portugal - Chloraprep laranja

Sweden - Chloraprep färgad

UK - ChloraPrep with Tint

This leaflet was last revised in 06/2024.

©2024 BD. BD, the Logo and BD ChloraPrep are property of Becton, Dickinson and Company.

License Number:

PL 05920/0003

Becton Dickinson U.K Limited
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Address
1030 Eskdale Road, Winnersh Triangle, Wokingham, Berkshire, RG41 5TS, UK
Telephone
0800 917 8776
Medical Information Direct Line
0800 0437 546
Medical Information e-mail
[email protected]
E-mail
[email protected]
WWW
www.BD.com
Customer Care direct line
0800 917 8776