Chlorhexidine in alcohol pre-operative skin preparation spray
Certifications
Licensed medicinal product in the UK: Hydrex Pink Chlorhexidine Gluconate 0.5% w/v in 70% v/v DEB (pre Operative skin preparation).
Marketing Authorisation Holder: Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY, United Kingdom (per Summary of Product Characteristics).
MHRA licence number (PL 04509/0017) and General Sales List (GSL) legal category, indicating non Prescription availability for professional use under appropriate conditions.
Licensed medicinal product in the UK: Hydrex Pink Chlorhexidine Gluconate 0.5% w/v in 70% v/v DEB (pre Operative skin preparation).
Marketing Authorisation Holder: Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY, United Kingdom (per Summary of Product Characteristics).
MHRA licence number (PL 04509/0017) and General Sales List (GSL) legal category, indicating non Prescription availability for professional use under appropriate conditions.
Manufactured and quality Controlled in accordance with Good Manufacturing Practice (GMP) for medicinal products.
Description
Hydrex Spray (Pink) 200ml is an alcohol-based antimicrobial skin disinfectant containing Chlorhexidine Gluconate 0.5% w/v in 70% v/v denatured ethanol (DEB). The pink-coloured solution is supplied in a 200 ml spray bottle for pre-operative skin disinfection of intact skin prior to injections and minor surgical or invasive procedures. Combining the rapid, broad-spectrum action of alcohol with the persistent residual effect of chlorhexidine, Hydrex Pink provides immediate杀 reduction of skin flora and a long-lasting barrier (at least 6 hours) to help prevent microbial regrowth and reduce the risk of infection.
Bnefits
Indicated for pre-operative skin disinfection of intact skin prior to injections and minor surgical procedures.
Contains Chlorhexidine Gluconate 0.5% w/v in 70% v/v denatured ethanol (DEB) for combined immediate and residual antimicrobial activity.
Provides a persistent and cumulative effective barrier for at least 6 hours after application.
Fast-acting and effective against a wide range of Gram-positive and Gram-negative bacteria (including MRSA), yeasts, fungi and many viruses.
Alcohol-based formulation is quick-drying, helping to streamline pre-procedural preparation.
Pink colouring helps visual confirmation of the disinfected area on the skin.
Easy-to-use 200 ml spray format suitable for clinical environments and aesthetic practice skin preparation.
Licensed medicinal product (MHRA), providing assurance of quality, safety and efficacy when used as directed.
Indications
Pre-operative skin disinfection prior to minor surgical procedures.
Skin disinfection of intact skin prior to injections (e.g. aesthetic injectables, vaccinations, local anaesthetic injections).
Skin preparation and disinfection prior to other invasive procedures that require rapid, broad-spectrum antisepsis of intact skin.
Use where a quick-drying, alcohol-based chlorhexidine skin prep with residual effect is required.
Manufactured and quality Controlled in accordance with Good Manufacturing Practice (GMP) for medicinal products.
Broad Spectrum efficacy and residual protection documented in product literature and clinical guidance references cited in the SmPC (e.g., APIC guideline for handwashing and hand antisepsis).
Broad Spectrum efficacy and residual protection documented in product literature and clinical guidance references cited in the SmPC (e.g., APIC guideline for handwashing and hand antisepsis).
Chlorhexidine in alcohol pre-operative skin preparation spray
Active ingredients: Chlorhexidine Gluconate 0.5% w/v and 70% v/v denatured ethanol (DEB).
Supplied as a 200 ml spray formulation for topical application to intact skin.
Broad-spectrum antiseptic activity with rapid kill from alcohol and persistent residual effect from chlorhexidine.
Medicinal product formulation licensed for pre-operative skin preparation.
Packaging
200 ml spray bottle (Hydrex Pink Spray 0.5% in 70% DEB).
Pink-coloured solution supplied in a labelled container suitable for clinical use.
Outer packaging and leaflet include directions for use, safety information and regulatory details.
Ecolab order code for 12 x 200 ml spray pack: 3035080 (as per range documentation).
Usage
For external use only on intact skin. Apply topically as a pre-operative skin preparation prior to minor surgical procedures or injections, following local protocols.
Spray the product onto the area of intact skin to be disinfected, ensuring complete coverage of the intended field.
Allow the solution to dry thoroughly before performing the procedure; do not blot dry unless specifically recommended by local protocol.
Avoid pooling of the solution, particularly when using diathermy or other ignition sources; remove any excess fluid and ensure the area is dry to minimise fire risk.
Do not apply to open wounds, mucous membranes, or broken skin, and do not use in body cavities.
Avoid contact with eyes, brain, meninges, middle ear, or external ear in the presence of a perforated tympanic membrane.
Do not inject. The product is for topical skin application only.
Use with care in neonates and infants, and only if no suitable alternative is available and the expected benefit outweighs the risk; remove excess fluid promptly if used.
Follow institutional infection-prevention guidelines and the Summary of Product Characteristics (SmPC) for full directions and precautions.
Highly flammable: keep away from naked flames, ignition sources, and hot surfaces during and after application until the skin is completely dry.
Contraindications
Known hypersensitivity or allergy to chlorhexidine, alcohol, or any of the excipients in the formulation, including a history of chlorhexidine-related allergic reactions.
Do not use on patients with a history of severe allergic reactions or anaphylaxis to chlorhexidine-containing products.
Do not use in contact with eyes, brain, meninges, or the middle ear, or in the external auditory canal where there is a perforated tympanic membrane.
Do not inject, and do not use in body cavities.
Do not apply to open wounds, broken skin, or mucous membranes.
Use with extreme caution in neonates and infants (especially preterm or low birth-weight infants) because of the risk of chemical burns due to an immature skin barrier; only use if there is no safer alternative and the benefit outweighs the risk, and remove excess fluid immediately.
Avoid use in patients with extensive skin conditions where absorption or irritation risk may be increased unless advised by an appropriate clinician.
Adverse Effects
Hypersensitivity reactions, including rare but serious anaphylactic shock.
Allergic skin reactions such as contact dermatitis, pruritus (itching), erythema (redness), eczema, rash, urticaria (hives), skin irritation and blistering.
Chemical burns in neonates and infants, particularly premature infants, when used inappropriately or when excess solution is not removed.
Local irritation, stinging or burning sensation at the site of application.
Very rare risk of severe reactions if the product inadvertently enters the eyes, middle ear or other non-intended sites.
As with other alcohol-containing preparations, there is a fire hazard if used near ignition sources before complete drying.
Storage Conditions
Store in the original container at ambient room temperature as stated on the product label (typically below 25°C).
Keep the container tightly closed when not in use.
Store away from heat, hot surfaces, sparks, open flames and other ignition sources; the product is highly flammable.
Do not refrigerate or freeze unless specified otherwise on the pack.
Protect from direct sunlight and excessive heat.
Keep out of the sight and reach of children.
Do not use after the expiry date shown on the label and outer packaging.
Duration
Single-application, short-contact skin preparation immediately prior to injections or minor surgical procedures; provides a persistent antimicrobial barrier on the treated skin for at least 6 hours after application.
Onset
Rapid antimicrobial action within seconds to minutes after application due to the alcohol component, with residual activity maintained for at least 6 hours via chlorhexidine\u2019s persistent effect.
