Summary of Product Characteristics Updated 14-Jul-2023 | Thornton & Ross Ltd
Acriflex 0.25% w/w Cream
Savlon Burns & Scalds 0.25% w/w Cream
Acriflex 0.25% w/w Cream contains:
Chlorhexidine Gluconate 0.25% w/w (included as Chlorhexidine Gluconate 20% solution 1.25% v/w).
Excipients with known effect:
Cetostearyl Alcohol 6.0% w/w
For the full list of excipients, see sections 6.1.
Cream for topical administration to human beings.
For the treatment of minor burns and scalds, scratches, cuts and abrasions, sunburn blisters and infected cracked skin.
For general use, apply freely and smooth gently into the skin. For cuts abrasions, burns etc. spread freely and, if necessary, cover with a dressing.
There are no recommended dosage schedules as the product is for use as needed.
Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8)
Acriflex contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Acriflex should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8).
Keep away from the eyes.
Avoid contact with the brain, meninges and middle ear. Not for use in body cavities.
None known.
No harmful effects in human pregnancy have been reported. Nevertheless, like all medicines, care should be exercised during pregnancy and lactation.
None known.
Skin disorders
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.
Immune disorders
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).
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 Care Scheme at: www.mhra.gov.uk/yellowcard.
Overdosage is extremely unlikely. Chlorhexidine is poorly absorbed and systemic effects are unlikely even if large amounts are swallowed. However, gastric lavage followed by supportive measures may be used as appropriate.
Chlorhexidine is a bisbiguanide disinfectant which is effective against a wide range of vegetative gram-positive and gram-negative bacteria.
Not applicable.
Not applicable.
Arlatone 983 S
Cetostearyl Alcohol
Liquid Paraffin
Dimeticone 20
Glycerol (E422)
Quinoline Yellow Lake (E104)
Purified Water
None known.
Three years unopened.
None stated.
Internally lacquered aluminium, blind end tubes containing 30gm of product, closed with a polyolefin cap in a cardboard outer.
For general use, apply freely and smooth gently into the skin. For cuts, abrasions, burns, etc. spread freely and, if necessary, cover with a dressing.
There are no recommended dosage schedules as the product is for use as needed.
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
PL 00240/0116
29/03/2005
28/06/2023
Linthwaite, Huddersfield, West Yorks, HD7 5QH
+44(0)1484 848200
+44 (0) 1484 848164