Diprobase Ointment

1. Name Of The Medicinal Product

Diprobase Ointment

2. Qualitative And Quantitative Composition

No pharmacologically active components

3. Pharmaceutical Form

Ointment

4. Clinical Particulars

4.1 Therapeutic Indications

Diprobase Ointment is an emollient, moisturising and protective ointment for the follow-up treatment with topical steroids or in spacing such treatment. It may also be used as diluent for topical steroids. Diprobase Ointment is recommended for the symptomatic treatment of red inflamed, damaged, dry or chapped skin, the protection of raw skin areas and as a pre-bathing emollient for dry/eczematous skin to alleviate drying areas.

4.2 Posology And Method Of Administration

Adults and Children :

The ointment should be thinly applied to cover the affected area completely, massaging gently and thoroughly into the skin. Frequency of application should be established by the physician. Generally, Diprobase Ointment can be used as often as required.

4.3 Contraindications

Hypersensitivity to any of the components of the ointment is a contraindication to its use.

4.4 Special Warnings And Precautions For Use

None stated.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

None stated.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Skin reactions including pruritus, rash, erythema, skin exfoliation, burning sensation, hypersensitivity, pain, dry skin and bullous dermatitis have been reported with product use.

4.9 Overdose

None stated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Diprobase Ointment contains no active ingredients and has no pharmacological action. The ingredients have an emollient action on dry or chapped skin.

5.2 Pharmacokinetic Properties

Not applicable due to topical administration and direct action on the skin.

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 SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

White soft paraffin

Liquid paraffin.

6.2 Incompatibilities

None known.

6.3 Shelf Life

60 months (tube presentations)

36 months (500gm plastic jar with screw cap)

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

5, 50 and 100gm: Epoxy lined aluminium tubes with plastic caps.

500gm: White polypropylene jar closed with a white tamper-evident low density polyethylene screw cap.

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 00025/0574

9. Date Of First Authorisation/Renewal Of The Authorisation

12 April 1996/ 29 January 2007

10. Date Of Revision Of The Text

28 March 2011

11 LEGAL CATEGORY

GSL

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

DIPOIN/UK/03-11/7