2% chlorhexidine digluconate in 70% isopropyl alcohol sterile skin preparation pad
Certifications
Licensed medicinal product containing 2% w/v chlorhexidine digluconate in 70% v/v isopropyl alcohol for cutaneous use, with an authorised Summary of Product Characteristics and Patient Information Leaflet.
Marketing Authorisation held by GAMA Healthcare Ltd in relevant jurisdictions (e.g. HPRA/PA23120/001/001 in Ireland), with equivalent licensing overseen by the MHRA in the UK.
Manufactured and packaged under Good Manufacturing Practice (GMP) for pharmaceuticals.
Licensed medicinal product containing 2% w/v chlorhexidine digluconate in 70% v/v isopropyl alcohol for cutaneous use, with an authorised Summary of Product Characteristics and Patient Information Leaflet.
Marketing Authorisation held by GAMA Healthcare Ltd in relevant jurisdictions (e.g. HPRA/PA23120/001/001 in Ireland), with equivalent licensing overseen by the MHRA in the UK.
Manufactured and packaged under Good Manufacturing Practice (GMP) for pharmaceuticals.
Clinell / GAMA Healthcare operate quality management systems consistent with ISO standards for infection prevention products (e.g. ISO 9001 for quality management, as stated in corporate literature).
Description
HEXI PREP 1.5ml is a sterile, single-use, non-woven pad pre-impregnated with a licensed alcoholic solution containing 2% w/v chlorhexidine digluconate in 70% v/v isopropyl alcohol. It is designed for rapid and effective skin disinfection prior to invasive medical procedures such as blood culture collection, peripheral venepuncture and cannulation. Each sachet contains a 10 cm x 10 cm pad soaked with 1.5 ml of solution, providing an easy ‘apply and dry’ method that supports consistent application, quick drying times and a high level of antimicrobial activity. The product is a licensed medicinal product and an alternative to traditional bottled chlorhexidine–alcohol solutions, offering a glass-free, compact, point-of-care presentation that reduces waste and simplifies infection-prevention practice.
Bnefits
Provides rapid, broad-spectrum skin disinfection using 2% chlorhexidine digluconate in 70% isopropyl alcohol
Sterile, single-use pre-impregnated pad reduces risk of contamination compared with multi-use bottles
‘Apply & dry’ technique simplifies skin preparation and standardises practice for healthcare professionals
1.5 ml impregnated pad (10 cm x 10 cm) provides sufficient coverage for common peripheral access procedures
Designed specifically for skin disinfection before invasive medical procedures that do not require a clean-air environment
Glass-free, compact presentation reduces packaging, plastic use and waste volume compared with some alternatives
Convenient sachet format improves access at point of care and supports protocol compliance
Licensed pharmaceutical product with defined composition, indications and safety information
Indications
Disinfection of intact skin prior to invasive medical procedures that do not require a clean air environment
Skin preparation before blood culture collection
Disinfection of the site prior to routine venepuncture
Skin disinfection before peripheral venous cannulation
Skin disinfection before peripheral arterial line cannulation
Simple biopsy procedures on intact skin where alcoholic chlorhexidine is appropriate
Clinell / GAMA Healthcare operate quality management systems consistent with ISO standards for infection prevention products (e.g. ISO 9001 for quality management, as stated in corporate literature).
2% chlorhexidine digluconate in 70% isopropyl alcohol sterile skin preparation pad
Dialysis, fistula and graft site cleansing (where suitable and in line with local protocol)
General use in hospitals, clinics and community settings where licensed chlorhexidine–alcohol pads are required for pre-procedural skin antisepsis
Composition
Active substances (solution): 2% w/v chlorhexidine digluconate (equivalent to 20 mg chlorhexidine digluconate per mL of solution)
Active substances (solution): 70% v/v isopropyl alcohol (equivalent to 0.7 mL isopropyl alcohol per mL of solution)
Other ingredient: water (purified water) to 1 mL
Each sachet contains a sterile, non-woven pad impregnated with 1.5 mL of the alcoholic chlorhexidine solution
Formulation
Pharmaceutical form: cutaneous solution presented as a pre-impregnated sterile pad
Sterile, non-woven pad (10 cm x 10 cm) saturated with 1.5 mL of 2% w/v chlorhexidine digluconate in 70% v/v isopropyl alcohol
For cutaneous use only, on intact skin
Single-use, latex-free pad in an individual sachet
Packaging
Unit of issue: box of 100 individually wrapped sterile sachets
Each sachet contains one 10 cm x 10 cm non-woven pad impregnated with 1.5 mL solution
Outer carton labelled with product name, volume, composition, batch number and expiry date
Licensed medicinal product packaging with patient and professional information as per regulatory requirements
Usage
For cutaneous use only, on intact skin.
Select the appropriate HEXI PREP pad size (1.5 mL for smaller areas such as peripheral venepuncture and peripheral cannulation).
Tear open the sachet aseptically and remove the sterile pad.
Apply the pad to the designated skin area using a back-and-forth or circular motion, ensuring full coverage of the procedure site and the surrounding area in line with local policy.
Continue to scrub for the contact time specified in local protocols (commonly around 30 seconds).
Allow the area to air-dry completely; do not blot or wipe dry, and do not blow on the area.
Ensure the solution is fully dry before using any ignition source or heat/electrocautery, due to flammability.
Discard the used pad and sachet safely; single use only.
Healthcare staff should wear gloves and follow standard infection-prevention and control procedures throughout use.
Contraindications
Hypersensitivity or known allergy to chlorhexidine, isopropyl alcohol or any of the excipients.
Do not use on mucous membranes, in the eyes, in the mouth, in the ear canal, or on genital mucosa.
Do not use on open wounds, broken skin or severely damaged skin unless specifically directed by the prescribing information and local protocol.
Must not be injected or introduced into body cavities.
Use with particular care in newborn babies, especially those born prematurely, due to risk of local irritation and chemical burns with chlorhexidine–alcohol products.
Do not use in conjunction with other topical antiseptics or soaps that may inactivate chlorhexidine (for example, some anionic surfactants) on the same site without adequate rinsing.
Highly flammable: do not use near ignition sources or before the skin is completely dry.
Adverse Effects
Local skin reactions such as erythema, dryness, itching or irritation at the application site.
Contact dermatitis, including allergic contact dermatitis, may occur in sensitised individuals.
Rare but serious hypersensitivity reactions to chlorhexidine, including urticaria, angioedema, bronchospasm and anaphylactic shock, have been reported with chlorhexidine-containing products; discontinue use immediately and treat appropriately if such reactions occur.
In neonates and infants, especially premature babies, there is a risk of chemical burns with alcoholic chlorhexidine preparations if used inappropriately or under occlusion.
Prolonged or repeated use on the same site can increase the likelihood of irritation or dryness.
Storage Conditions
Do not store above 25°C (or as stated on the outer carton).
Store in the original carton to protect from light and to keep sachets together.
Keep sachets in a dry place and do not use if the sachet is damaged or leaking.
Do not use after the expiry date shown on the sachet and carton.
Keep out of the sight and reach of children.
As the solution contains alcohol, keep away from open flames and sources of ignition.
Duration
Single-application use immediately prior to each invasive procedure. HEXI PREP is used as a one-off skin preparation step per procedure and may be repeated for subsequent procedures as required under clinical supervision and local protocols.
Onset
Antimicrobial activity begins rapidly upon application and contact with the skin, with significant reduction in skin microbial counts typically achieved within minutes of application and drying. Persistence of effect depends on procedure and site but is designed to provide effective pre-procedural skin antisepsis.
