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DIPROBASE CREAM

Active substance(s): PARAFFIN SOFT WHITE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

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

Fertility, 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.
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
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 polypropylene jar with pump presentation – 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.
A 500g polypropylene jar with a high density polyethylene follower plate and a pump
system. The pump system consists of a polypropylene cylinder, a polypropylene
head, a polypropylene pump body and a high density polyethylene piston with a glass
valve and a high density polyethylene valve.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Bayer plc, Consumer Care Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
UK

8

MARKETING AUTHORISATION NUMBER(S)

PL 00010/0658

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
12 April 1996

10

DATE OF REVISION OF THE TEXT
30/06/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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