D
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
Diprobase Cream
.
