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CHLORAPREP WITH TINT 2% W/V / 70% V/V CUTANEOUS SOLUTION

Active substance(s): CHLORHEXIDINE GLUCONATE / ISOPROPYL ALCOHOL

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DATE

REV

XX/XX

J

05/29/14

I

DCN

SUMMARY OF CHANGE
1. Rewrite to accomodate required PRAC changes
2. 2nd page, 1st column, replaced 'Do not store above 25ºC. Avoid freezing.' with 'This medicine does not require any
special temperature storage conditions.'
3. 2nd page, 2nd column, replaced 'Do not store above 25ºC.' with 'This medicine does not require any special
temperature storage conditions.'
4. Change last revised date to 08/2015

TBD

1. 1st page, 2nd column, added "Reporting of side effects If you get any side effects, talk to your doctor or nurse. This
includes..."
2. 2nd page, 2nd column, added "United Kingdom Yellow Card Scheme..." & "Ireland IMB Pharmacovigilance, Earlsfort
Terrace, IRL - Dublin 2..." & "Malta ADR Reporting, The Medicines Authority, Post-Licensing Directorate..." & "By
reporting side effects you can help provide more information on the safety of this medicine."
3. 2nd page, 3rd column, changed last revised date to "05/2014"

2014-05-16

To review remaining history - See Rev. H

SWATCHES

DOCUMENT ID

Artwork No. 6-775000EU, ChloraPrep Tint Applicator Insert - UK/MT/IE Pg 1 of 2

Black

Font List
ChloraPrep® with Tint 2% w/v /
70% v/v Cutaneous Solution
12 pt Frutiger Bold Condensed
Chlorhexidine Gluconate ... to 26-ml
11 pt Frutiger Bold Condensed
Body Copy
9 pt Frutiger Bold/Light Condensed
‘See other side for
further instructions.’
10 pt Frutiger Bold Italic

2.7813
Fold

ChloraPrep® with Tint
2% w/v / 70% v/v
Cutaneous Solution

Perforation

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

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

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.
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.

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.

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

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. (See Section 6.)

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

Warnings and precautions
ChloraPrep with Tint is for external use only.
ChloraPrep with Tint should not be used:
- near eyes or delicate linings (mucous membranes), as
it may cause irritation. If it does get into the eye 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).
Use with care in newborn babies, especially those born
prematurely. ChloraPrep with Tint may cause chemical skin
burns.
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

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.

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.

See other side for further instructions.

ChloraPrep® with Tint
2% w/v / 70% v/v
Cutaneous Solution

Chlorhexidine Gluconate / Isopropyl Alcohol
3 ml / 10.5 ml / 26 ml
The following information is intended for medical
or healthcare professionals only:
Instructions for using ChloraPrep® with Tint
applicators:
For cutaneous use. For external use only.
- Remove the applicator from the wrapper and hold it
with the sponge facing downward.
- Squeeze the applicator once only:
   -  26 ml squeeze lever on handle
   -  other products, squeeze wings
- Do not repeatedly pinch or pump the wings in an
attempt to accelerate the saturation of the foam.
- Gently press the sponge against the patient’s skin in
order to apply the antiseptic solution. Once the solution
is visible on the skin, use gentle back and forth strokes
to prep the site for 30 seconds.
- The 26 ml applicator includes two swabs. Clean intact
umbilicus with enclosed swabs when applicable.
(Moisten swabs by pressing against solution-soaked
sponge applicator.)
- Allow the covered area to air dry completely.
ChloraPrep with Tint can be left on the skin post
procedure.
Maximum coverage areas:
- 3 ml   15 cm x 15 cm
- 10.5 ml   25 cm x 30 cm
- 26 ml   50 cm x 50 cm

8.5

Precautions for Use:
- Allow ChloraPrep with Tint to dry completely before
starting any medical procedure. Do not use electrocautery
procedures until the skin is completely dry. Do not use
excessive quantities and do not allow the solution to pool
in skin folds or under the patient or drip on sheets or
other material in direct contact with the patient.
- Use with care in neonates, especially those born before
32 weeks of gestation and within the first 2 weeks
of life. ChloraPrep with Tint may cause chemical skin
burns.
- Do not use near eyes or mucous membranes, as it may
cause irritation. If it does get into the eye or the mucous
membranes, it should be washed quickly with plenty of
water.
- Do not use on open skin wounds, broken or damaged
skin.
- ChloraPrep with Tint should not come into contact with
neural tissues or the middle ear.
- Chlorhexidine is incompatible with soap and other
anionic agents.

See other side for further instructions.

8.375

El Paso Documentation Use Only

Date:

CC:

All Dimensions
shown in inches

Artwork No. 6-775000EU, ChloraPrep Tint Applicator Insert - UK/MT/IE Pg 2 of 2

Font List
ChloraPrep® with Tint 2% w/v /
70% v/v Cutaneous Solution
12 pt Frutiger Bold Condensed
Chlorhexidine Gluconate ... to 26-ml
11 pt Frutiger Bold Condensed
Body Copy
9 pt Frutiger Bold/Light Condensed
‘See other side for
further instructions.’
10 pt Frutiger Bold Italic

2.7813
Perforation

- Alcohol should not be brought into contact with some
vaccines and skin test injections (patch tests). If in
doubt, consult the vaccine manufacturer’s literature.
- Do not apply the solution in an over vigorous manner
to very fragile or sensitive skin. After repeated use,
local skin reaction may occur including: erythema or
inflammation, itching, dry and/or flaky skin and local
application site pain. At the first sign of local skin
reaction, stop application of ChloraPrep with Tint.
Special precautions for disposal
The solution is flammable. Do not use while smoking
or near any naked flames or strong heat source. Avoid
exposure of the container and contents to naked flames
during use, storage and disposal. Discard the applicator
after use as per clinical waste procedures.

Storage Procedures
ChloraPrep with Tint is for single use only and is sterile
until the packaging is opened. Do not use ChloraPrep with
Tint after the expiry date stated on the label or carton.
The expiry date refers to the last day of that month. This
medicine does not require any special temperature storage
conditions. Store in the original packaging.

Marketing Authorisation Holder
CareFusion U.K. 244 Ltd.
The Crescent, Jays Close,
Basingstoke, Hampshire RG22 4BS
United Kingdom
ChloraPrep® is a registered trademark of
CareFusion Corporation or one of its subsidiaries.

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.
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, red, dry
or inflamed where you have used the product as a skin
wash, stop using it and talk to your doctor or pharmacist.

Please refer to the Summary of Product Characteristics for
ChloraPrep with Tint for further detailed information.

Active Substances
The active substances in ChloraPrep with Tint are
2% w/v chlorhexidine gluconate and 70% v/v isopropyl
alcohol. The inactive ingredients in ChloraPrep with Tint
are purified water and Sunset Yellow (E110).

Fold

If the side effect gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
nurse immediately.
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:
United Kingdom
Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard

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:
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
CareFusion U.K. 244 Ltd.
The Crescent, Jays Close,
Basingstoke, Hampshire RG22 4BS
United Kingdom
+44(0)-800-0437-546
The Manufacturer of ChloraPrep® with Tint is
Insight Health Limited
Unit A Bridgefields,
Welwyn Garden City, Hertfordshire AL7 1RX
United Kingdom

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
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 out of the reach and sight 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

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
Greece – SteriPrep
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

8.5

This leaflet was last revised in 08/2015.
ChloraPrep® is a registered trademark of
CareFusion Corporation or one of its subsidiaries.
License Numbers:
UK: PL 31760/0001
IE: PA 1435/1/1
MT: MA 700/00101
Artwork 6-775000EU  JXXXX

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El Paso Documentation Use Only

Date:

CC:

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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