This information is intended for use by health professionals

1. Name of the medicinal product

DERMOL™ 600 BATH 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

White bath additive.

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 use in the bath: For adults, children and the elderly: Add up to 30 ml to a bath of warm water (more or less according to the size of the bath and individual patient requirements). For infants: Add up to 15ml to a bath of warm water (more or less according to the size of the bath and individual patient requirements). Soak for 5 to 10 minutes. Pat dry.

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 special precautions.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Although the bath 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.

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.

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. Dermol 600 Bath Emollient 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

Dermol 600 Bath Emollient 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, Dermol 600 Bath Emollient 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%; 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

600 ml plastic bottle with a measuring cap.

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)

00173/0155.

9. Date of first authorisation/renewal of the authorisation

13 July 2009.

10. Date of revision of the text

February 2015.