Diprobath

1. Name Of The Medicinal Product

Diprobath

2. Qualitative And Quantitative Composition

Light Liquid Paraffin 46.0% w/w

Isopropyl Myristate 39.0% w/w

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Liquid bath emollient

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of dry skin conditions and other hyperkeratoses, including those associated with dermatitis and eczema.

To be diluted in bath water for external application.

4.2 Posology And Method Of Administration

Adults including elderly patients :

25ml or approximately 2.5 capsful to be diluted in a bath of water (100 L approximately). For particularly dry skin the quantity of oil emollient may be doubled.

Children :

10ml or one capful is sufficient for children's baths.

Frequency and duration of bathing will depend on the type and severity of the conditions, but generally 2 to 3 baths should be taken weekly.

4.3 Contraindications

Known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

As Diprobath deposits a film of oil over the skin, care should be taken to avoid slipping in the bath.

The following warning will appear on the label :

'Take care when entering or leaving the bath which may be more slippery than usual'.

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

None known.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Both active ingredients have established emollient properties which are of relevance to use as a bathing emollient.

5.2 Pharmacokinetic Properties

Pharmacokinetic principles are not involved due to direct topical application.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Laureth-4

6.2 Incompatibilities

None Known

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store upright at a temperature below 30°C.

6.5 Nature And Contents Of Container

50 ml and 500 ml: natural opaque high-density polyethylene (HDPE) single neck bottle with a polypropylene screw cap. Mounted in the cap is a polyethylene liner containing a polytetrafluoroethylene (PTFE) venting disc.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UK

8. Marketing Authorisation Number(S)

PL 00025/0584

9. Date Of First Authorisation/Renewal Of The Authorisation

11 November 1991 / 10 January 2007

10. Date Of Revision Of The Text

19 January 2011

11 LEGAL CATEGORY

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© Merck Sharp & Dohme Limited 2011. All rights reserved.

Diprobath UK/01-11/5