Emulsiderm Emollient

1. Name Of The Medicinal Product

EMULSIDERM™ EMOLLIENT

2. Qualitative And Quantitative Composition

Liquid Paraffin 25.0% w/w; Isopropyl Myristate 25.0% w/w; Benzalkonium Chloride 0.5% w/w.

3. Pharmaceutical Form

Pale blue bath additive and cutaneous emulsion.

4. Clinical Particulars

4.1 Therapeutic Indications

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.

4.2 Posology And Method Of Administration

For adults, children and the elderly:

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; 300 ml bottle - use 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.

4.3 Contraindications

Sensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep away from the eyes. For external use only. Keep out of the reach and sight of children. Take care to avoid slipping in the bath.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No known side effects.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sorbitan Stearate; Polysorbate 60; Industrial Methylated Spirit 95%; Methylthioninium Chloride; Purified Water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Always replace the cap after use.

6.5 Nature And Contents Of Container

Supplied in plastic bottles; a 300 ml bottle with a measuring cap, and a 1 litre bottle with a measuring cup.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing Authorisation Number(S)

00173/0036.

9. Date Of First Authorisation/Renewal Of The Authorisation

13 July 2009.

10. Date Of Revision Of The Text

July 2009.