Diprobase Cream

1. Name Of The Medicinal Product

Diprobase Cream

2. Qualitative And Quantitative Composition

No pharmacologically active components.

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

Diprobase Cream is an emollient, moisturising and protective cream for the follow-up treatment with topical steroids or in spacing such treatment. It may also be used as diluent for topical steroids. Diprobase Cream 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 cream should be applied to the dry skin areas as often as is required and rubbed well into the skin.

4.3 Contraindications

There are no absolute contraindications to the use of the cream other than hypersensitivity to any of the ingredients.

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 Cream contains no active ingredients and has no pharmacological action. The ingredients provide emollient, moisturising 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

Chlorocresol

Macrogol Cetostearyl Ether (Cetomacrogol)

Cetostearyl alcohol

Liquid paraffin

White soft paraffin

Phosphoric acid

Sodium dihydrogen phosphate

Sodium hydroxide

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

15, 50 and 100gm aluminium tubes - 60 months

500gm pump presentations – 36 months

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

50, 100 and 15gm aluminium epoxy lined membrane tubes with plastic caps.

500gm polypropylene piston pack with polyethylene cap and daplen pump, disc and tube or PVC cap, polypropylene pump, polyolefin disc and HDPE tube or

500gm polypropylene jar (container) with a polypropylene dispenser head and cover, the pump system consists of a polyethylene follower plate, a polypropylene pump cylinder, a polyethylene piston with a glass and a polypropylene valve.

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 00025/0575

9. Date Of First Authorisation/Renewal Of The Authorisation

12 April 1996 / 12 April 2001

10. Date Of Revision Of The Text

21 March 2011

11 LEGAL CATEGORY

GSL

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

DipCrm/UK/03-11/7