Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
PurPrep 8.3% w/w / 72.5% w/w cutaneous solution in single-dose container
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Iodinated povidone, Isopropyl alcohol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
PurPrep is a sterile cutaneous solution, containing the active substances iodinated povidone, and isopropyl alcohol. The cutaneous solution is available in a plastic applicator with a sponge tip on one end. PurPrep is an antiseptic used for disinfection of intact skin before invasive medical procedures (including surgery), to help reduce microorganisms (bacteria and yeasts) that can potentially cause infection. PurPrep is indicated in adults, adolescents, and children 1 year of age or older. 2.
What you need to know before you take it
e PurPrep
Do not use PurPrep –
If you are allergic to iodinated povidone, and isopropyl alcohol or any of the other ingredients of this medicine (listed in section 6).
–
On children less than 1 year of age. On patients with dermatitis herpetiformis; On patients with hyperthyroidism and other thyroid dysfunction.
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Warnings and precautions Talk to your doctor or nurse before PurPrep is used. PurPrep is for single and external use on intact skin only. PurPrep should not be administered to anyone with a potential history of allergy to iodinated povidone compounds. PurPrep must not be used: –
near eyes or mucous membranes, as it may cause irritation. If it accidentally occurs, it should be washed quickly with plenty of water.
–
on open skin wounds or as a general skin cleanser.
–
in direct contact with neural tissue and the middle ear
If symptoms of an anaphylactic reaction are detected, application of PurPrep should be stopped immediately. If the solution has been applied in an over-vigorous manner to very fragile or sensitive skin or after repeated use, application-site reactions such as pruritus, erythema, rash, papules, and vesicles may occur (see section 4). At the first sign of any of these reactions, applications of PurPrep 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. Where occlusive dressings are to be applied to areas previously exposed to PurPrep, care must be taken to ensure no excess product is present prior to application of the dressing. The solution is flammable. When using PurPrep, use in a well-ventilated area. Do not use ignition sources such as cigarettes, naked flames or a strong heat source until the skin is completely dry. Thyroid disorder and renal insufficiency PurPrep should be used with caution in patients with thyroid disorder (i.e., hyperthyroidism, mild nodular goitre) and in patients with renal insufficiency due to prolonged time of elimination. Very rare cases of iodine-induced hyperthyroidism have been reported with iodinated povidone containing products. With repeated application, there may be a potential for increased drug absorption, skin irritation and thyroid disorder (see sections 3 and 4). If re-operation is necessary within a few days following the application of PurPrep, the use of a preoperative antiseptic that does not contain iodinated povidone, or close monitoring of thyroid function, should be determined by the clinician.
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Children PurPrep is contraindicated on children less than 1 year due to an increased iodine absorption that can occur from topical administration of iodinated povidone to immature skin, especially in pre-term infants. The use of alcohol-based solutions, for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates (see section 4). Other medicines and PurPrep Tell your doctor or nurse if you are using, have recently used or might use any other medicines, specifically: –
a vaccine or skin test injection (patch test used to test for allergies). those that contain proteins such as those in blood which may impair efficacy. disinfectants containing mercury due to the risk of chemical burns following the formation of mercury iodide. certain antiseptics (octenidine), as dark discolouration can occur at the treated areas. those that contain hydrogen peroxide or taurolodine, as oxidation can weaken the activity of the drug. those that contain silver-containing disinfectants or wound dressings that can form silver iodine. lithium therapy, as rare instances of hypothyroidism have been reported. the results of certain thyroid tests may be affected.
Pregnancy, breast-feeding and fertility PurPrep should be used with caution during pregnancy or breastfeeding, since absorption of iodine into the mother's blood (even through intact skin) and excretion into human breast milk may occur. During pregnancy and lactation, PurPrep, like all iodine preparations, should only be administered following a very careful assessment of the risk/benefit by the doctor. Driving and using machines PurPrep has no or negligible influence on the ability to drive and use machines. 3.
How to take it
PurPrep
The antiseptic solution within the PurPrep 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. The medicinal product is for cutaneous use.Your doctor or nurse will rub the sponge over your skin, covering the skin area that needs to be prepared. Depending on your medical procedure, more than one applicator may be used. PurPrep is only used on the intact skin and each applicator is only used once. PurPrep is for single use only.
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If you have any further questions on the use of this medicinal product, ask your doctor or nurse. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. A very rare but serious side effect is anaphylaxis (may affect up to 1 in 10,000 people). If you develop swelling of the face, lips, tongue or throat; wheezing or difficulty breathing; feeling faint and dizzy; a strange metallic taste in the mouth; or collapse, you may be having an anaphylactic reaction. Stop using PurPrep and talk to your doctor, nurse or pharmacist. Other allergic-type skin and sensitisation reactions have been reported rarely (may affect up to 1 in 1,000 people). If you experience any of the following symptoms, the product application should be stopped immediately: pruritus (itching), erythema, skin rash, papules, vesicles, dry or inflamed skin, and contact dermatitis. Very rare instances of hyperthyroidism and angiodema may occur (may affect up to 1 in 10,000 people). The following possible effects have been described with PurPrep after prolonged use, application over large coverage areas or on non-intact skin (frequency cannot be estimated from the available data): –
Chemical and thermal burns, associated with the use of alcohol-based solutions Exfoliative dermatitis Hypothyroidism in specific patient populations Metabolic acidosis Electrolyte imbalance Renal insufficiency
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist 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 it
PurPrep
Keep this medicine out of the sight and reach of children. 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. PurPrep is flammable. Do not store above 30°C. Avoid exposure of the container and contents to naked flames during use, storage and disposal.
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Store in the original packaging; PurPrep is sterile unless the seal is broken. After opening, the medicinal product should be used immediately. Do not throw away any 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 PurPrep contains –
The active substances are iodinated povidone and isopropyl alcohol. Each 1 ml solution contains 72.5 mg of iodinated povidone and 633 mg of isopropyl alcohol. Each applicator with 10.5 ml solution contains 761 mg of iodinated povidone (72.5 mg/ml) and 6646 mg of isopropyl alcohol (633 mg/ml).
–
Each applicator with 26 ml solution contains 1884 mg of iodinated povidone (72.5 mg/ml) and 16456 mg of isopropyl alcohol (633mg/ml). The other ingredients are methacrylic acid-methyl methacrylate copolymer (1:2), acrylates / octylacrylamide copolymer, macrogol 400, 2-amino-2-methyl-1-propanol (95%) and purified water.
What PurPrep looks like and contents of the pack PurPrep is a cutaneous solution contained in applicators containing either 10.5 ml or 26 ml of solution. The solution is hermetically sealed within a type I glass ampoule housed in a single-use sterile applicator. The 10.5 ml applicator contains 1 type I glass ampoule, while the 26 ml contains 2 type I glass ampoules of 13 ml each. When the applicator is activated, the solution is released from the glass ampoule(s) and allowed to flow into the foam on top of the applicator body for cutaneous application. The packaging consists of a lidding material sealed to a polymeric film creating a "pouchlike" packet surrounding the applicator. The final packaged applicator is sterilised using ethylene oxide. Pack sizes: 1 applicator containing 10.5 ml cutaneous solution. 25 applicators each containing 10.5 ml cutaneous solution. 1 applicator containing 26 ml cutaneous solution. Not all pack sizes may be marketed
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Marketing Authorisation Holder and Manufacturer Becton Dickinson UK Ltd, 1030 Eskdale Road, Winnersh, Wokingham, RG4, 5TS, United Kingdom Customer contact for adverse events or medical information inquiries: 0800 0437 546
The Manufacturer of PurPrep is Insight Health Limited, Unit A Bridgefields, Welwyn Garden City, Hertfordshire AL7 1RX United Kingdom
Licence number: PLGB 05920/0007 This leaflet was last revised in January 2024 ———————————————————————————————————————–The following information is intended for healthcare professionals only: Instructions for using PurPrep: –
PurPrep may be used on patient populations 1 year of age or older. Single use applicator. With repeated application, there may be a potential for increased drug absorption, skin irritation and thyroid disorder. PurPrep should only be applied after a careful consideration in elderly patients with thyroid disorder. For cutaneous use. For external use only. Remove the applicator from the wrapper and hold it with the sponge facing downward. Pinch wings or press lever once only to activate the applicator. Do not repeatedly pinch or pump in an attempt to accelerate the saturation of the foam. Press the sponge against the patient's skin in order to apply the antiseptic solution. Once the solution is visible on the skin, use back and forth strokes to prep the site for 30 seconds. Allow the covered area to air dry completely.
PurPrep solution can be left on the skin post procedure. Maximum coverage areas: –
10.5 ml: 25 cm x 30 cm 26 ml: 50 cm x 50 cm
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Precautions for Use: –
–
–
Allow PurPrep solution to dry completely before starting any medical procedure. Do not use during electrocautery procedures or with other ignition sources until the skin is completely dry. Do not use while smoking or near any naked flames or strong heat sources. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or to drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to PurPrep, care must be taken to ensure no excess product is present prior to application of the dressing. Do not use on children less than 1 year of age because of the potential for excessive skin irritation and absorption of iodine. PurPrep may cause chemical burns in neonates. Use with caution in women who are breastfeeding due to the potential for transient hypothyroidism in the nursing newborn. Do not use near eyes or mucous membranes. 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 or as a general skin cleanser. Do not use on broken or damaged skin and in direct contact with neural tissue or the middle ear. 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, application-site reactions such as pruritus, erythema, rash, papules, and vesicles may occur. At the first sign of local skin reaction, stop application of PurPrep. Do not use in patients with known hypersensitivity to PurPrep solution or any of its components, especially in those patients with a history of possible allergic reaction to iodinated povidone compounds. If symptoms of an anaphylactic reaction are detected, application of PurPrep should be stopped immediately. Use with caution in patients with thyroid disorder (i.e hyperthyroidism, mild nodular goitre) and patients with renal insufficiency due to prolonged time of elimination. If re-operation within a few days following application of PurPrep is necessary, the use of a preoperative antiseptic not containing iodinated povidone, or close monitoring of thyroid function is advised.
Treatment of overdose In case of accidental ingestion of large quantities of product, institute symptomatic and supportive treatment with particular attention to the renal and thyroid function. Incompatibilities Iodine, as iodinated povidone, may react with organic matter such as blood proteins. It should not be used with reducing agents, silver, mercury, taurolidine, disinfectants containing silver, octenidine, hydrogen peroxide or in patients receiving concomitant lithium therapy. Absorption of iodine from iodinated povidone, through either healthy or damaged skin, may interfere with thyroid functions tests. However, there is little absorption of iodine through intact skin. Special precautions for disposal The solution is flammable. Do not store above 30°C. Avoid exposure of the container and contents to naked flames during use, storage, and disposal. Discard the applicator after use
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as per clinical waste procedures. Please refer to the Summary of Product Characteristics for PurPrep for further detailed information.
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Frequently asked questions about PurPrep 8.3% w/w / 72.5% w/w cutaneous solution in single-dose container
How do I take PurPrep 8.3% w/w / 72.5% w/w cutaneous solution in single-dose container?
PurPrep 8.3% w/w / 72.5% w/w cutaneous solution in single-dose container comes as solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in PurPrep 8.3% w/w / 72.5% w/w cutaneous solution in single-dose container?
The active substance in PurPrep 8.3% w/w / 72.5% w/w cutaneous solution in single-dose container is iodinated povidone, isopropyl alcohol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for PurPrep 8.3% w/w / 72.5% w/w cutaneous solution in single-dose container, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get PurPrep 8.3% w/w / 72.5% w/w cutaneous solution in single-dose container without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: iodinated povidone, isopropyl alcohol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
This medicinal product is to be used as antiseptic on intact skin prior to invasive medical procedures (including surgery) and has bactericidal and levurocidal activity (see section 5.1).
PurPrep is indicated in adults, adolescents, and children 1 year of age or older.
4.2. Posology and method of administration
Posology
PurPrep may be used on patient populations 1 year of age or older.
Single use applicator. With repeated application, there may be a potential for increased drug absorption, skin irritation and thyroid disorder (see section 4.4).
Paediatric population
PurPrep should not be used in children less than 1 year of age because of the potential for excessive skin irritation and increased drug absorption resulting in transient hypothyroidism (see section 4.3).
Elderly
PurPrep should only be applied after a careful consideration in elderly patients with thyroid disorder.
Method of administration
For cutaneous use.
1 PurPrep applicator contains either 10.5 ml or 26 ml cutaneous solution.
The appropriate PurPrep applicator should be chosen based on the invasive procedure being undertaken and the size of the area to be prepped to avoid excess of solution and the risk of product pooling.
Applicator
Maximum Coverage Area (cm x cm)
For Procedures such as:
10.5 ml
26 ml
25 x 30
50 x 50
- Minor and major surgical procedures.
- Implantable device placement.
- Prosthetic device placement or removal.
- Midline, Peripheral Intravascular Central Catheter (PICC) & CVC insertion and maintenance.
- Cardiac catheterisation and Cardiac Cath Lab procedures.
- Interventional Radiology procedure.
The applicator is removed from the wrapper and held with the sponge facing downward. In order to activate the 10.5 ml applicator, the wings are squeezed. For the 26 ml applicator, the lever is pressed. This will break the ampoule containing the antiseptic solution, which is released onto the sponge with a controlled flow. Wings or lever are pinched or pressed respectively once only to activate the applicator and release the antiseptic. Do not repeatedly pinch or pump in an attempt to accelerate the saturation of the sponge. The broken ampoule remains safely contained within the applicator. The sponge is pressed against the patient's skin in order to apply the antiseptic solution. Once the solution is visible on the skin, back and forth strokes should be applied to prep the site for 30 seconds. The area covered should be allowed to air dry completely.
It is recommended that PurPrep remains on the skin post-procedure to provide continued antimicrobial activity. If removal is necessary, remove with soap and water or alcohol.
4.3. Contraindications
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1;
- Children less than 1 year of age;
- Patients with dermatitis herpetiformis;
- Patients with hyperthyroidism and other thyroid dysfunction.
4.4. Special warnings and precautions for use
The solution is flammable. PurPrep should be used in a well-ventilated area. Electrocautery procedures or other ignition sources must not be used until the skin is completely dry.
Any soaked materials, drapes or gowns should be removed before proceeding with the intervention. The solution must not be used in excessive quantities and must not pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to PurPrep, care must be taken to ensure no excess product is present prior to application of the dressing.
Single use applicator, for external use only and on intact skin.
PurPrep contains iodine as iodinated povidone. Iodine, as iodinated povidone, may induce hypersensitivity, including skin reaction and sensitisation. The prevalence of hypersensitivity to iodine, as iodinated povidone is not known but available literature suggests this is likely to be rare. PurPrep should not be administered to anyone with a potential history of hypersensitivity to iodine as the iodinated povidone compound (see sections 4.3 and 4.8).
The solution is an irritant to eyes and mucous membranes. It should therefore be kept away from these areas. If the solution comes in contact with the eyes, they should be washed promptly and thoroughly with water.
PurPrep must not be used:
- on open skin wounds or as a general skin cleanser.
- on broken or damaged skin or mucous membranes.
In addition, direct contact with neural tissue or the middle ear must be avoided.
Use with caution in women who are breastfeeding due to the potential for transient hypothyroidism in the nursing newborn (see section 4.6).
It is important to ensure that the correct method of application is strictly followed (see section 4.2). Prolonged skin contact with alcohol containing solutions should be avoided unless necessary. When the solution has been applied in an over-vigorous manner to very fragile or sensitive skin or after repeated use, application-site reactions such as pruritus, erythema, rash, papules, and vesicles may occur (see section 4.8). At the first sign of local skin reaction, application of PurPrep should be stopped.
Anaphylactic reactions
If symptoms of an anaphylactic reaction are detected, application of PurPrep should be stopped immediately (see section 4.8).
Thyroid disorder and renal insufficiency
PurPrep should be used with caution in patients with thyroid disorder (i.e hyperthyroidism, mild nodular goitre) and patients with renal insufficiency due to prolonged time of elimination. Very rare cases of iodine-induced hyperthyroidism have been reported with products containing iodine as iodinated povidone.
With repeated application, there may be a potential for increased drug absorption, skin irritation and thyroid disorder (see sections 4.2 and 4.8).
If re-operation within a few days following application of PurPrep is necessary, the use of a preoperative antiseptic that does not contain iodine as iodinated povidone, or close monitoring of thyroid function, should be determined by the clinician.
Paediatric population
PurPrep should not be used on children less than 1 year of age because of the potential for excessive skin irritation and absorption of iodine (see section 4.3 and 4.8).
The use of alcohol-based antiseptic solutions on skin prior to invasive procedures has been associated with chemical burns in neonates (see section 4.8).
4.5. Interaction with other medicinal products and other forms of interaction
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.
It is expected that iodine, as iodinated povidone, reacts with proteins such as blood which may impair efficacy.
PurPrep solution must not be used concomitantly or immediately following disinfectants containing mercury due to the risk of chemical burns following the formation of mercury iodide.
PurPrep solution must not be used concomitantly or immediately after application of octenidine as transient dark discoloration can occur at the concerned area.
PurPrep solution should not be used with hydrogen peroxide or taurolidine, as oxidation can weaken the activity of the drug.
The concomitant application of PurPrep solution and silver-containing disinfectants or wound dressings can form silver iodine.
Absorption of iodine through the skin is minimal. Misuse, such as application to non-intact skin and/or repeated daily use can result in hypothyroidism of individuals receiving concomitant lithium therapy.
Effect on diagnostic tests:
During the application of iodine as iodinated povidone, uptake of radio-iodine by the thyroid gland may be reduced; this can lead to disturbances in thyroid scanning, PBI (protein-bound iodine) determination and radioiodine diagnostics and make planned radioiodine therapy impossible. A waiting period of at least 1-2 weeks should be observed after discontinuing the iodine as iodinated povidone treatment, before conducting a new thyroid scan.
4.6. Fertility, pregnancy and lactation
Pregnancy and Breastfeeding
During pregnancy and lactation, PurPrep, like all iodine preparations, should only be administered following a very careful assessment of the risk/benefit by the physician.
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of 8.3% w/w iodine as iodinated povidone, and 72.5% w/w isopropyl alcohol.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
PurPrep should be used with caution in women who are pregnant or breast-feeding, since a minimal absorption of iodine to the mother's blood even through intact skin and excretion into human milk may occur.
After application of PurPrep, monitoring of thyroid function in the child may be indicated. In the case of hypothyroidism, consider early treatment with thyroid hormones until normalisation of thyroid function.
Further, oral absorption of PurPrep by the infant through contact with the treated part of the nursing mother's body must be avoided.
Fertility
The effects on human reproduction have not been studied.
4.7. Effects on ability to drive and use machines
PurPrep has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The following frequencies are used for the evaluation of adverse reactions:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from data available)
System Organ Class
Rare
Very Rare
Not Known
Immune System Disorders
Hypersensitivities
Anaphylactic reactions
Metabolic and Nutrition Disorders
Hyperthyroidism
Metabolic Acidosis
Hypothyroidism
Electrolyte imbalance
Skin and Subcutaneous Tissue Disorders
Erythema
Skin irritation
Pruritus
Vesicles
Rash
Papules
Contact dermatitis
Angioedema
Chemical burns
Thermal burns
Exfoliative dermatitis
Renal and Urinary Disorders
Renal insufficiency
Hyperthyroidism: in patients with a history of thyroid disease (see section 4.4), after prolonged use or application over large coverage areas.
Hypothyroidism: after prolonged use or application over large coverage areas, increase of the absorption of iodine through non-intact skin.
Electrolyte imbalance, renal insufficiency, metabolic acidosis: may occur after absorption of large amounts of iodine as iodinated povidone, due to application on large coverage areas.
Chemical burns: cases have been associated with the use of alcohol-based solutions, especially in neonates.
Application-site reactions such as pruritus, erythema, rash, papules, and vesicles may occur when the solution has been applied in an over-vigorous manner to very fragile or sensitive skin or after repeated use.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
In case of accidental ingestion of large quantities of the medicinal product, institute symptomatic and supportive treatment with particular attention to the renal and thyroid function.
💬 Ask about this leaflet
Ask anything about PurPrep 8.3% w/w / 72.5% w/w cutaneous solution in single-dose container. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.