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DIPROBASE OINTMENT

Active substance(s): PARAFFIN SOFT WHITE

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SUMMARY OF PRODUCT CHARACTERISTICS
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

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 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 and 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 25ÂșC

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
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 00010/0659

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/01/1986

10

DATE OF REVISION OF THE TEXT
20/07/2015

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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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