Emulsiderm

Emulsiderm Emollient

(as Benzalkonium Chloride Solution)

For excipients see section 6.1.

Pale blue cutaneous emulsion and bath additive.

An antimicrobial bath emollient for use as an aid in the treatment of dry and pruritic skin conditions, especially eczema/dermatitis, ichthyosis or xeroderma. It permits the rehydration of the keratin by replacing lost lipids, and its antiseptic properties assist in overcoming secondary infection.

Adults, including the elderly and children:

For use in the bath:

Add 7 - 30 ml Emulsiderm to a bath of warm water (more or less according to the size of the bath and individual patient requirements).

1 litre bottle - use graduated measuring cup provided.

50 - 500 ml bottles - ½ to 2 capfuls.

Soak for 5 - 10 minutes. Pat dry.

For application to the skin:

Rub a small amount of undiluted emollient into the dry areas of skin until absorbed.

Sensitivity to any of the ingredients.

Keep away from the eyes.

For external use only.

Keep out of the sight and reach of children.

Take care to avoid slipping in the bath.

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

None known

No known side effects.

None known.

Although the emollient has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction discontinue treatment.

These reactions are very rare (<1/10,000 based on spontaneous reporting) and may be irritant or allergic in nature. Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area.

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.

Not applicable.

For dry skin conditions it is important to add an emollient to the bath water. Emulsiderm contains 50% of oils emulsified in water as well as the well-known antiseptic, benzalkonium chloride which assists in overcoming secondary infection.

Emulsiderm contains 0.5% of the quaternary ammonium antiseptic, benzalkonium chloride. The large positively charged cation is readily adsorbed from the formulation onto negatively charged bacterial cell surfaces, thereby conferring substantial antimicrobial activity. Even at extended dilution, it is particularly effective against Staphylococcus aureus, a bacterium which is known to colonise the skin in large numbers in patients with eczema, especially atopic eczema. Apart from its emollient properties, Emulsiderm therefore also helps to prevent and overcome secondary infection which may exacerbate the eczematous condition.

The safety and efficacy of the emollients (liquid paraffin and isopropyl myristate) and the antiseptic (benzalkonium chloride) in topical dosage forms have been well established over many years of widespread clinical usage.

Sorbitan Stearate

Polysorbate 60

Industrial Methylated Spirit 95%

Methylthioninium Chloride

Purified Water

None known.

36 months in unopened container.

Do not store above 25°C.

Always replace the cap after use.

a) 30 ml high density polyethylene bottle fitted with low density polyethylene dispensing plug and Bakelite screw cap with low density polyethylene liner, or

50, 100, 125, 150, 200, 250, 300, 350 or 500 ml high density polyethylene bottle fitted with low density polyethylene dispensing plug and spigotted polypropylene screw cap, or

1000 ml high density polyethylene bottle and high density polyethylene screw cap with low density polyethylene liner.

For bottle sizes greater than the unit dose (30 ml), the screw cap incorporates a 10 ml or 15 ml measure, or a 30 ml measuring cup is supplied.

b) 10 ml paper/polyethylene/foil/polyethylene laminate sachet. (packaged into unit cartons in appropriate multiples to match the above bottle capacities)

Not applicable

Diomed Developments Limited

T/A Dermal Laboratories

Tatmore Place

Hitchin

Hertfordshire

SG4 7QR

United Kingdom

PL 00173/0036

22 April 1981/13 July 2009 (unlimited validity)

20/11/2019