Summary of Product Characteristics Updated 14-Dec-2023 | Thornton & Ross Ltd
Savlon Bites & Stings Pain Relief Gel
Savlon Antiseptic and Pain Relief Gel
| Active ingredients: | Lidocaine Hydrochloride | 2.0% w/w |
| Zinc Sulphate | 1.0% w/w | |
Cetrimide | 0.5% w/w | |
| Excipient(s) with known effect: | ||
| Propylene glycol (E1520) | 10.0% w/w | |
For the full list of excipients, see section 6.1
Gel
Colourless, viscous gel with a characteristic menthol odour.
For the symptomatic relief of pain, itching, irritation, and for antiseptic protection. For use in insect bites and stings, and skin reactions such as nettle rash, caused by contact with plants.
Adults and children over 12 years: Apply a small amount to the affected area with a fingertip. Repeat if required up to 3-4 times daily.
Children under 12 years: Not recommended (insufficient data available).
Route of administration: For cutaneous use.
Patients with a known hypersensitivity to any ingredient should not use the product.
Contact with the eyes should be avoided. For external use only.
Not suitable for animal bites.
Keep out of the sight and reach of children.
Excipient warnings:
This medicine contains 10%w/w propylene glycol (E1520) per application, which may cause skin irritation.
No known interactions with other drugs.
There are no known adverse effects in normal use of this product in pregnancy and lactation.
Exposure to systemically absorbed lidocaine from the product is low. The active ingredients have been in use for many years and no special precautions are considered necessary.
There are no known adverse effects on driving and using machinery.
The active ingredients have been in use for many years at much higher levels of exposure and no precautions are considered necessary for use in driving and using machinery.
Rarely, skin irritation and sensitisation may occur.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Overdosage effects are unlikely as the systemic dose from this topical product is likely to be very low.
Three pharmacological effects are provided:
Lidocaine hydrochloride is a local anaesthetic of the amide type which is widely used for local application to the skin and mucous membranes. It produces surface anaesthesia by diminishing or preventing the conduction of sensory nerve impulses.
Cetrimide is a quaternary ammonium antiseptic. As well as having emulsifying and detergent properties, it has antibacterial activity against gram-positive organisms and to a lesser extent against some gram-negative organisms.
Zinc sulphate has astringent and soothing properties.
The product is intended for local action. Lidocaine hydrochloride is well-absorbed through mucous membranes and more slowly absorbed through intact skin.
No relevant information is available other than that given in other sections of the SPC.
Hydroxypropyl methylcellulose
Polysorbate 20
Nonoxynol 9
Propylene Glycol (E1520)
Levomenthol
Purified Water
None known.
36 months.
Shelf life after opening of the tube: 3 months
Do not store above 30° C.
Laminated tube consisting of aluminium foil coated internally and externally with low density polyethylene or high density polyethylene.
Pack size: 3g, 20g
No special requirements.
Thornton & Ross Ltd.
Linthwaite,
Huddersfield,
HD7 5QH, UK
PL 00240/0468
05/10/2006
04/12/2023
Linthwaite, Huddersfield, West Yorks, HD7 5QH
+44 (0) 1484 848164
+44(0)1484 848200
