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Naseptin Nasal Cream

Naseptin Nasal Cream

Naseptin

Prescription-only antimicrobial nasal cream (antibiotic and antiseptic medicine)
  • Naseptin Nasal Cream is an MHRA Authorised medicinal product in the UK, with a marketing authorisation held by Alliance Pharmaceuticals Limited; it is listed on the MHRA substance database under neomycin sulfate with specific files for Naseptin Nasal Cream.
  • Classified as a Prescription Only Medicine (POM) in the UK, as indicated in national formularies and medicines databases.
  • Approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) are published on the electronic Medicines Compendium (emc) and other official medicines portals, providing regulatory details on composition, indications, dosing, contraindications and adverse effects.
  • Listed in Irish medicines databases (medicines.ie) with licence number PA2325/009/001, strength 0.1% + 0.5%, ATC code D06AX/D06AX04, and dosage form nasal cream, confirming regulatory alignment across markets.
  • Subject to MHRA/Alliance Pharmaceuticals alerts and safety communications, including notification of formulation change to remove arachis (peanut) oil excipient; prescribers and pharmacists are advised to exercise caution when prescribing and dispensing due to the reformulation.
  • Alliance Pharmaceuticals lists Naseptin Nasal Cream in its official product range and highlights the need to report adverse reactions through the MHRA Yellow Card Scheme or directly to the company’s pharmacovigilance department.
Topical nasal cream containing neomycin sulfate and chlorhexidine dihydrochloride

Description

Naseptin Nasal Cream is a prescription-only antimicrobial cream used to treat and prevent infections inside the nose. It contains two active ingredients: chlorhexidine dihydrochloride 0.1% w/w, an antiseptic effective against a wide range of Gram-positive and Gram-negative bacteria, yeasts and dermatophyte fungi, and neomycin sulfate 0.5% w/w, an aminoglycoside antibiotic with rapid bactericidal activity against many Gram-positive organisms (including Staphylococcus aureus) and a wide range of Gram-negative organisms. Naseptin is indicated for the treatment of nasal infection with staphylococci and for eradication of staphylococcal carriage from the nasal passages. The cream is applied directly to the nares (nostrils), usually four times daily for 10 days, as directed in the SmPC and by a prescriber. It is commonly used in primary and secondary care to eradicate nasal carriage of S. aureus, including in strategies to reduce recurrent staphylococcal infections or surgical site infection risk. The current UK formulation has been reformulated to remove arachis (peanut) oil as an excipient following an MHRA/Alliance Pharmaceuticals alert; prescribers are advised to exercise caution when switching patients from the previous arachis-oil-containing formulation.

Bnefits

  • Combines an antiseptic (chlorhexidine dihydrochloride) and an antibiotic (neomycin sulfate) to provide broad antimicrobial activity against nasal pathogens including Staphylococcus aureus.
  • Indicated specifically for treatment of nasal infection with staphylococci and eradication of staphylococcal carriage from the nasal passages, supporting infection-control strategies.
  • Topical application directly inside the nostrils delivers active agents at the site of colonisation or infection, helping to clear local bacterial load.
  • Widely used in clinical practice as part of decolonisation regimens for S. aureus carriers, particularly where mupirocin is unavailable or unsuitable, as reflected in UK formulary guidance.
  • Cream formulation is white, non-greasy and water miscible, making it suitable for intranasal use and comfortable for patients.
  • Reformulated version removes arachis (peanut) oil, reducing the risk of peanut-related allergic reactions while maintaining antimicrobial efficacy.

Indications

  • Antimicrobial cream intended for application to the nares (nostrils) for treatment of nasal infection with staphylococci.
  • Eradication of staphylococcal carriage from the nasal passages, particularly Staphylococcus aureus, as specified in SmPC and HPRA/MHRA summaries.
  • Used in clinical settings as part of decolonisation protocols to reduce the risk of staphylococcal wound and surgical site infections, in conjunction with other infection-control measures (per formulary and literature references).
  • Topical treatment of infected nasal crusts and nasal vestibulitis caused by susceptible organisms, as reflected in UK and Irish usage information.
  • Use only on the inside of the nose; not intended for use on eyes, ears, skin elsewhere or systemic infection.

Composition

  • Active ingredients (per 1 g cream): chlorhexidine dihydrochloride 0.1% w/w; neomycin sulfate 0.5% w/w.
  • Chlorhexidine dihydrochloride: antiseptic effective against a wide range of Gram-positive and Gram-negative vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses; inactive against bacterial spores except at elevated temperatures.
  • Neomycin sulfate: aminoglycoside antibiotic with rapid bactericidal activity against Gram-positive organisms including staphylococci and many Gram-negative organisms; strains of Pseudomonas aeruginosa are resistant.
  • Excipients (current UK reformulated product; full list as per SmPC): not all are publicly enumerated in summaries, but peanut (arachis) oil has been removed from the new formulation following MHRA/Alliance alert. The original formulation historically contained arachis oil, which could induce allergic responses in patients with peanut or soya allergy.
  • Nasal cream base: white, non-greasy, water-miscible cream vehicle suitable for intranasal application (detailed excipient composition given in full SmPC text).

Formulation

  • Pharmaceutical form: nasal cream.
  • Description: white, non-greasy, water-miscible cream intended for application inside the nose (to the nares).
  • Qualitative and quantitative composition: chlorhexidine dihydrochloride 0.1% w/w and neomycin sulfate 0.5% w/w in a nasal cream base.
  • Route of administration: intranasal (to the inside of each nostril) only.
  • The cream is supplied in an aluminium tube with a suitable orifice for expressing a small amount of cream onto the finger for application to the nasal mucosa.
  • The current marketed UK formulation has been reformulated to remove arachis (peanut) oil as an excipient due to allergen concerns, per MHRA/Alliance alert.
  • ATC code: D06AX04 (other topical antibiotics) in many references; some sources list D06AX for combination topical antibiotics and antiseptics.

Packaging

  • Standard pack size: 15 g aluminium tube of nasal cream with screw cap, as listed on emc, medicines.ie and pharmacy sites.
  • Tube is supplied in a cardboard carton containing the Patient Information Leaflet (PIL).
  • Labelling includes product name (Naseptin Nasal Cream), active ingredients (chlorhexidine dihydrochloride and neomycin sulfate), strength (0.1% / 0.5%), route of administration (nasal), batch number, expiry date, storage instructions and marketing authorisation details.
  • Some national formularies describe the presentation as "Naseptin nasal cream (Alliance Pharmaceuticals Ltd) 15 gram".
  • In the provided Aestheticsrx Pharma listing, the product image shows a branded carton and tube consistent with the 15 g UK pack.

Usage

  • Naseptin Nasal Cream is for use in the nose only (intranasal). Do not apply to eyes, ears, or other areas.
  • Adults and children: the usual regimen described in clinical references is to apply a small amount of cream to the inside of each nostril four times daily for 10 days. A fingertip amount is placed on the little finger and gently rubbed around the inside of each nostril; the nostrils are then pressed together to spread the cream evenly (full instructions in PIL/SmPC).
  • Before application, the nose may be gently cleaned or blown to remove crusts as directed by a healthcare professional.
  • Patients should wash their hands before and after applying the cream to reduce the risk of contamination or transmission of bacteria.
  • Treatment duration and frequency may be adjusted by the prescriber depending on the indication and patient response, but standard courses generally last up to 10 days; the full course should be completed even if symptoms improve early.
  • Naseptin should not be used for longer than prescribed due to risk of developing resistant organisms or increased risk of sensitisation to neomycin or chlorhexidine.
  • If a dose is missed, it should be applied as soon as remembered, unless it is nearly time for the next dose; patients should not double the amount of cream to make up for a missed application.
  • Patients should be instructed to stop using Naseptin and seek medical advice if they develop signs of allergic reaction (e.g. swelling of the lips, face or throat; difficulty breathing; severe rash) or significant irritation inside the nose.
  • Use in patients with known sensitivity to chlorhexidine, neomycin, or any excipient must be avoided; prescribers should check allergy history prior to prescribing.
  • Patients should follow the full instructions in the Patient Information Leaflet and any additional advice from their doctor or pharmacist.

Contraindications

  • Hypersensitivity to neomycin sulfate, chlorhexidine dihydrochloride or to any of the excipients in the formulation.
  • Current or previous history of hypersensitivity to other aminoglycoside antibiotics, due to possible cross-sensitisation with neomycin.
  • Use in patients who have had previous allergic reactions to chlorhexidine-containing products (e.g. antiseptic mouthwashes, skin cleansers).
  • Not for use in the eyes, ears or on large areas of damaged skin; intranasal use only as directed.
  • The original formulation containing arachis (peanut) oil was contraindicated in patients with peanut or soya allergy; the current reformulated UK product has removed arachis oil, but caution and allergy checking remain important.
  • Use with caution or avoid in patients with known or suspected neomycin-induced ototoxicity or nephrotoxicity where systemic absorption could be an issue (although systemic absorption from nasal application is expected to be low).
  • Full list of contraindications and precautions is given in section 4.3 of the SmPC; prescribers should consult the current SmPC before prescribing.

Adverse Effects

  • Local irritation in the nose (e.g. burning, stinging, soreness, dryness) is among the more common adverse effects; usually mild and transient.
  • Allergic reactions, including contact dermatitis or more generalised hypersensitivity reactions, may occur due to neomycin or chlorhexidine; symptoms can include rash, itching, swelling and, rarely, anaphylaxis.
  • Prolonged or repeated use can increase the risk of contact sensitisation to neomycin, potentially leading to more widespread allergic dermatitis on future exposure to neomycin-containing products.
  • As with other topical aminoglycosides, there is a theoretical risk of ototoxicity or nephrotoxicity if significant systemic absorption occurs, particularly if applied to large areas of damaged skin or used inappropriately; however, such systemic effects are very unlikely with correctly used intranasal cream.
  • Overgrowth of non-susceptible organisms (including fungi) may occur with prolonged use of topical antibiotics; treatment should be discontinued and medical advice sought if new infection or worsening occurs.
  • Post-marketing surveillance reports and the PIL advise patients to stop using Naseptin and seek immediate medical attention if they experience signs of severe allergic reaction (such as difficulty breathing, swelling of the face or throat, or severe skin rash).
  • The SmPC and PIL contain a full list of reported adverse reactions and their frequencies; healthcare professionals should review these documents for detailed safety information.

Storage Conditions

  • Do not store above 25°C.
  • Do not freeze.
  • Keep the tube tightly closed when not in use.
  • Store in the original carton to protect from light and to keep out of the sight and reach of children.
  • Do not use after the expiry date stated on the tube and carton.
  • Any unused medicinal product or waste material should be disposed of in accordance with local requirements; patients are typically advised not to dispose of medicines via wastewater or household waste and to return unused medicine to a pharmacy.

Duration

Typical treatment duration is up to 10 days, with a standard recommended regimen of four applications per day for 10 days for eradication of staphylococcal nasal carriage, as described in the SmPC and online prescribing information. Duration may be adjusted by the prescriber based on clinical judgement, but prolonged continuous use beyond the prescribed course is not recommended.

Onset

Not publicly quantified in hours; UK and online pharmacy sources state that improvement in nasal infections with neomycin/chlorhexidine combinations is often seen within 2\u20133 days of starting treatment, but individual response varies and the full course should be completed as prescribed.

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