Hibiscrub 4% w/v Cutaneous Solution 500ml

Hibiscrub 4% w/v Cutaneous Solution 500ml

Hibiscrub

Topical antiseptic medicinal product
  • Licensed medicinal product (chlorhexidine gluconate 4% w/v cutaneous solution) with an approved Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC).
  • Manufactured under Good Manufacturing Practice (GMP) standards for pharmaceuticals.
  • Subject to pharmacovigilance monitoring through the MHRA Yellow Card scheme in the UK.
  • Complies with relevant European and UK medicinal Product labelling and quality regulations for topical antiseptics.
Antimicrobial skin cleanser / surgical scrub (chlorhexidine gluconate 4% w/v)

Description

Hibiscrub 4% w/v Cutaneous Solution 500ml is a licensed antimicrobial skin cleanser containing chlorhexidine gluconate 4% w/v (40 mg/ml). It is used for pre- and post-operative hand and skin disinfection, antiseptic handwashing on the ward, and general skin disinfection before or after clean procedures. The red, slightly viscous solution provides rapid and persistent antimicrobial action against a wide range of gram-positive and gram-negative bacteria, yeasts, fungi and some viruses. It contains emollients to help care for the skin with frequent use and is widely used in hospitals, clinics and community settings, including aesthetic clinics, to reduce the risk of infection.

Bnefits

  • Contains 4% w/v chlorhexidine gluconate, providing broad-spectrum antimicrobial activity against bacteria, yeasts, fungi and some viruses
  • Helps prevent infections by killing germs on the skin and reducing microbial load
  • Long-lasting residual effect, with continued antimicrobial activity for up to 6 hours after application when used as directed
  • Binds to the skin to form a protective antimicrobial layer rather than being absorbed systemically
  • Suitable for pre-operative surgical hand disinfection and antiseptic handwashing on wards
  • Used for pre- and post-operative skin disinfection and general skin cleansing before/after clean procedures
  • Includes emollient ingredients to help maintain skin condition with repeated use
  • Available in a convenient 500 ml bottle size, ideal for regular clinical and home use
  • Widely used and trusted in healthcare settings, including theatres, wards, outpatient and aesthetic clinics

Indications

  • Pre-operative surgical hand disinfection for healthcare professionals
  • Antiseptic handwashing on hospital wards and in clinical settings
  • Pre-operative skin preparation and disinfection before surgery or clean procedures
  • Post-operative skin antisepsis for patients after surgery, excluding the operation site when advised
  • Antiseptic handwashing after handling infected materials
  • General antimicrobial skin cleansing where a chlorhexidine-based wash is appropriate and prescribed
  • Pre- and post-procedure skin preparation in dental, veterinary and aesthetic/dermatology practice (according to local protocols)

Composition

  • Active ingredient: Chlorhexidine gluconate 4% w/v (40 mg/ml)
  • Poloxamer 237
  • Isopropyl alcohol
  • Lauryl dimethyl amine oxide
  • Glycerol
  • Macrogol 7 glycerol cocoate
  • Gluconolactone
  • Perfume (Herbacol) containing multiple potential fragrance allergens (including but not limited to: Amyl cinnamal, Amylcinnamyl alcohol, Anisyl alcohol, Benzyl alcohol, Benzyl benzoate, Benzyl cinnamate, Benzyl salicylate, Cinnamal, Citral, Citronellol, Coumarin, d-Limonene, Eugenol, Farnesol, Geraniol, Hexyl cinnamaldehyde, Hydroxymethylpentyl-cyclohexenecarboxaldehyde, Isoeugenol, Lilial, Linalool, Methyl heptine carbonate, Oak moss and Tree moss)
  • Ponceau 4R (E124)
  • Sodium hydroxide (for pH adjustment)
  • Purified water

Formulation

  • Pharmaceutical form: cutaneous solution
  • Clear, red, slightly viscous detergent antiseptic solution with a characteristic odour
  • Topical antiseptic for external use on skin only
  • Supplied as a ready-to-use liquid; no dilution required for most indications (unless specifically directed in local protocols)
  • Belongs to the biguanide class of antiseptics (chlorhexidine gluconate)

Packaging

  • White plastic bottle containing 500 ml of solution with screw cap or flip-top closure (depending on batch/market)
  • Other available pack sizes include 125 ml, 250 ml and 5 litre bottles, but the Fillers Direct product is the 500 ml presentation
  • Bottle and carton labelled with product name, strength (4% w/v), active ingredient, batch number, expiry date and regulatory information

Usage

  • For external use only. Do not inject. Do not use inside the body or in internal spaces.
  • Avoid contact with eyes, ears (especially with perforated eardrum), brain, meninges and other neural tissues. If contact occurs, rinse thoroughly with water and seek medical advice if irritation persists.
  • Pre-operative surgical hand disinfection: wet hands and forearms. Wash with approximately 5 ml of Hibiscrub, following a standard surgical handwashing technique for about one minute. Clean fingernails with an appropriate brush or scraper and rinse thoroughly. For full pre-operative preparation, repeat the wash a second time for about two minutes, then rinse thoroughly and dry with a sterile towel.
  • Antiseptic handwashing on the ward: wet hands and forearms, apply about 5 ml of Hibiscrub and wash for around one minute. Rinse thoroughly and dry with a clean towel or paper towels.
  • Whole-body wash before surgery (as directed by a healthcare professional): typically 25 ml is used as a soap solution to wash the whole body in the bath or shower on at least two occasions (e.g. day before and day of surgery), paying special attention to high-risk areas such as around the nose, underarms, umbilicus and groin. Rinse thoroughly and dry with a clean towel after each wash.
  • Post-operative wash (excluding the operation site if instructed): usually performed from the third day after surgery using the same method as the pre-operative whole-body wash, unless otherwise directed.
  • Do not mix Hibiscrub with regular soaps or detergents on the skin at the same time, as they may reduce its effectiveness; if other products are used, rinse well before applying Hibiscrub.
  • Always follow the instructions in the package leaflet and any additional directions from a doctor, pharmacist, nurse or local infection-prevention protocol.

Contraindications

  • Known hypersensitivity or allergy to chlorhexidine gluconate or any of the other ingredients (including the Herbacol fragrance components or Ponceau 4R/E124).
  • Should not be used in body cavities, on the meninges, in the middle ear or in direct contact with nerve tissue.
  • Avoid use in the eyes; if accidental contact occurs, rinse immediately and thoroughly with water.
  • Use with care in newborn babies, especially those born prematurely, as chlorhexidine preparations may cause chemical skin burns in this group.
  • Do not inject or use internally.
  • Use with caution on severely damaged, very dry or inflamed skin unless specifically directed by a healthcare professional.

Adverse Effects

  • Local skin reactions such as irritation, erythema (redness), dryness, itching and eczema or dermatitis.
  • Urticaria (hives), rash or blistering at the site of application.
  • Serious allergic reactions (anaphylaxis) have been reported with chlorhexidine-containing products, with symptoms such as difficulty breathing, facial or tongue swelling, weakness, collapse and rash; treatment must be stopped immediately and emergency medical attention sought.
  • In very rare cases, inflammation of the membranes of the brain and spinal cord has been reported when chlorhexidine has come into direct contact with these tissues (not applicable when used correctly on intact skin).
  • In newborns and premature infants, inappropriate use may cause chemical skin burns.
  • Brown staining of fabrics may occur if clothes or bedding that have been in contact with chlorhexidine are later exposed to common household bleaches containing hypochlorites.

Storage Conditions

  • Keep out of the sight and reach of children.
  • Do not store above 25°C.
  • Store in the original container and outer carton to protect from light.
  • Do not use after the expiry date printed on the bottle and carton (EXP). The expiry date refers to the last day of the indicated month.
  • Do not freeze.
  • Dispose of unused product or expired bottles in accordance with local pharmaceutical waste regulations; do not pour down drains or into household waste.

Duration

Used intermittently or repeatedly for as long as pre- and post-operative skin disinfection or antiseptic handwashing is required, according to medical advice and local protocols. Pre-operative whole-body washes are usually carried out on the day before and the day of surgery, with an additional post-operative wash typically on day three after surgery or as directed by the healthcare team.

Onset

Antimicrobial activity begins rapidly on application, with significant reduction in skin microorganisms typically within seconds to minutes of contact. Binding of chlorhexidine to the skin provides persistent activity that can continue to reduce microbial counts for up to approximately 6 hours after use.

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