Aciclovir 5% Cream (2g)

Generic

Topical antiviral medicine (GSL/P in UK)

Nucleoside analogue antiviral cream for herpes labialis (cold sores)

Aciclovir 5% w/w cream presentations (including 2 g tubes) are authorised medicinal products in the UK with MHRA marketing authorisations (e.g. Pinewood Cold Sore Cream PL 04917/0066).
Products in this category are classified as General Sales List (GSL) or Pharmacy medicines for the treatment of herpes labialis, subject to the conditions specified in their licences.
Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for aciclovir 5% w/w cold sore creams are published on the electronic medicines compendium (emc) and MHRA product database.
As a licensed medicinal product, aciclovir 5% cream is manufactured in compliance with EU/UK Good Manufacturing Practice (GMP) and subject to ongoing pharmacovigilance and safety monitoring via the MHRA Yellow Card scheme.

Aciclovir 5% w/w cream presentations (including 2 g tubes) are authorised medicinal products in the UK with MHRA marketing authorisations (e.g. Pinewood Cold Sore Cream PL 04917/0066).
Products in this category are classified as General Sales List (GSL) or Pharmacy medicines for the treatment of herpes labialis, subject to the conditions specified in their licences.
Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for aciclovir 5% w/w cold sore creams are published on the electronic medicines compendium (emc) and MHRA product database.
As a licensed medicinal product, aciclovir 5% cream is manufactured in compliance with EU/UK Good Manufacturing Practice (GMP) and subject to ongoing pharmacovigilance and safety monitoring via the MHRA Yellow Card scheme.

Nucleoside analogue antiviral cream for herpes labialis (cold sores)

Description

Aciclovir 5% Cream (2g) is a licensed topical antiviral medicine containing aciclovir, a nucleoside analogue active against herpes simplex virus (HSV). It is supplied by DD Group as a generic 5% w/w cream in a 2 g tube for use on cold sores affecting the lips and face (herpes labialis). According to UK SmPCs for aciclovir 5% w/w cold sore creams, each gram of cream contains 50 mg aciclovir in a white to off-white oil-in-water cream base. The cream is indicated for the treatment of herpes labialis by inhibiting viral DNA replication in infected cells, thereby helping to shorten the duration of outbreaks, reduce pain and local symptoms, and promote healing when applied early in the course of infection.

Bnefits

Topical antiviral therapy for herpes simplex virus infections of the lips and face (herpes labialis).
Contains aciclovir, a well-established nucleoside analogue antiviral that selectively inhibits viral DNA polymerase in HSV-infected cells.
Helps to reduce the duration and severity of cold sore outbreaks when started early (ideally at prodrome or first lesion appearance).
Convenient 5% w/w cream in a small 2 g tube suitable for a single course of treatment for a typical cold sore episode.
Licensed medicine with MHRA-approved SmPC and PIL, including established clinical data showing modest reductions in healing time and pain duration versus vehicle cream.
Topical application results in minimal systemic absorption, with plasma levels generally below the limit of detection after cutaneous use.
General Sales List/Pharmacy medicine status in the UK for suitable patients, while also used within professional dental and facial aesthetics settings for managing herpes labialis.

Indications

Treatment of herpes simplex virus infections of the lips and face (herpes labialis).
Use only on cold sores affecting the lips and surrounding facial skin; not for genital herpes or ocular herpes infections.
Not recommended for use in immunocompromised patients except on the advice of a doctor, according to UK SmPCs for aciclovir 5% cold sore creams.

Composition

Active ingredient: aciclovir 5% w/w – each gram of cream contains 50 mg aciclovir.
Representative UK SmPC (Pinewood Cold Sore Cream, PL 04917/0066) lists the following excipients: stearoyl macrogolglycerides, dimeticone, cetyl alcohol, liquid paraffin, white soft paraffin, propylene glycol, purified water.
The DD Group generic 2 g tube is described simply as Aciclovir 5% Cream (2g); specific excipient listing for that pack must be confirmed from the actual carton and patient leaflet supplied with the product.

Formulation

Pharmaceutical form: cream for cutaneous use.
Qualitative/quantitative composition consistent with UK aciclovir 5% w/w cold sore creams: 50 mg aciclovir per gram in a white to off-white oil-in-water cream base.
Pharmacotherapeutic group: direct-acting antiviral, nucleosides and nucleotides excluding reverse transcriptase inhibitors; ATC code J05AB01.
Pack size: 2 g aluminium tube with polyethylene screw cap (as described in the Pinewood Cold Sore Cream SmPC; the DD Group generic listing is for the same nominal 2 g presentation).

Packaging

2 g tube of aciclovir 5% w/w cream, supplied as a small aluminium tube with polyethylene screw cap according to representative UK SmPCs for 2 g cold sore cream presentations.
Outer carton packaging (for MHRA-licensed products such as Pinewood Cold Sore Cream) includes the product name, strength, active ingredient, marketing authorisation number and regulatory labelling; the DD Group listing does not display carton artwork and the exact branding on the pack they supply is not publicly specified.
The DD Group product page identifies the item as “Generic Aciclovir 5% Cream (2g)” with product code 700310 and generic code ACYCR2, sold as a restricted general pharmacy item within their facial aesthetics range.

Usage

For cutaneous use only on the lips and face. Do not apply inside the mouth, on mucous membranes, in or around the eyes, or on the genitals (according to UK SmPCs for aciclovir 5% w/w cold sore creams).
Treatment should be started as soon as possible after the first signs of infection (prodromal tingling, itching or burning) or when lesions first appear.
Adults and children: apply a thin layer of cream to the affected area and immediately adjacent skin 5 times daily at approximately 4-hour intervals during the day, omitting the night-time application.
Continue treatment for 4 days. If healing has not occurred, treatment may be continued for up to 10 days. Patients should consult a doctor if lesions are still present after 10 days.
Patients should wash their hands before and after applying the cream and avoid unnecessary rubbing of lesions or touching them with towels to reduce the risk of aggravation or spread of infection.
Use in immunocompromised patients is not recommended without medical advice; such patients should be referred to a physician for management of herpes infections.
Elderly patients do not require special dosage adjustments for topical use according to UK SmPCs.

Contraindications

Known hypersensitivity to aciclovir.
Known hypersensitivity to valaciclovir.
Known hypersensitivity to propylene glycol or to any of the excipients listed in the relevant SmPC for the aciclovir 5% cream supplied.
Use on mucous membranes (such as inside the mouth, vagina or on the eye) is contraindicated; the cream is intended only for cold sores on lips and adjacent facial skin.
Not recommended for use in immunocompromised patients (e.g. HIV infection, bone marrow transplant, cancer treatment) except on the advice of a doctor, according to UK SmPCs.

Adverse Effects

Uncommon (≥1/1,000 to <1/100): transient burning or stinging at the site of application, mild dryness or flaking of the skin, itching at the application site.
Rare (≥1/10,000 to <1/1,000): erythema, contact dermatitis (when patch testing is performed, reactions are more often attributable to cream base components such as excipients rather than aciclovir itself).
Very rare (<1/10,000): immediate hypersensitivity reactions including angioedema and urticaria.
Overdose from topical use is unlikely. Ingestion of the entire contents of a 2 g tube of 5% cream is not expected to cause significant adverse effects based on SmPC data for aciclovir creams.

Storage Conditions

Do not store above 25°C.
Do not refrigerate.
Keep the tube tightly closed when not in use.
Shelf life typically 3 years unopened and 6 weeks after first opening for representative UK products such as Pinewood Cold Sore Cream; users should check the specific expiry information printed on the pack they receive.
Keep out of the sight and reach of children.

Duration

Standard course is 4 days of treatment with topical applications 5 times daily; if healing is incomplete, treatment may be continued for up to 10 days. If lesions persist beyond 10 days, medical advice should be sought, as stated in UK SmPCs for aciclovir 5% w/w cold sore creams.

Onset

Not publicly listed (SmPCs describe clinical outcomes such as modest reductions in healing time and pain duration compared with vehicle, but do not provide a precise time-to-onset of symptomatic relief).