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ECZEDERM 8.5% / 5% W/W CREAM

Active substance(s): LIQUID PARAFFIN / WHITE SOFT PARAFFIN / LIQUID PARAFFIN / WHITE SOFT PARAFFIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Eczederm 8.5% / 5% w/w Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin Ph Eur

8.5% w/w

Liquid Paraffin Ph Eur 5.0% w/w
For full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Cream.
A smooth white cream.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Eczederm 8.5% / 5% w/w Cream is an emollient, moisturising and protective
cream 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. Eczederm 8.5% / 5% w/w
Cream can be used as an adjunct to topical steroids, where a steroid-sparing
effect is desirable. It can be used to space treatments with topical steroids.
Eczederm 8.5% / 5% w/w Cream can also be used as a follow-up to treatment
with topical steroids.

4.2

Posology and method of administration
Posology
For use by adults, children and the elderly.
There are no special dosage recommendations for either elderly patients or children.

Method of administration
For cutaneous use only.
The cream should be applied to the dry skin areas as often as is required and rubbed
well into the skin

4.3

Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Section
6.1.

4.4

Special warnings and precautions for use
One of the ingredients in Eczederm 8.5% / 5 %w/w, cetostearyl alcohol, may
cause local skin reactions (e.g. contact dermatitis).

4.5

Interaction with other medicinal products and other forms of interaction
None known. No interaction studies have been undertaken.

4.6

Pregnancy and lactation
Pregnancy
No special precautions or dosage requirements are indicated for use during
pregnancy.
Lactation
No special precautions or dosage requirements are indicated for use during lactation.

4.7

Effects on ability to drive and use machines
Eczederm 8.5%/5%w/w Cream has no or negligible influence on the ability to drive
and use machines

4.8

Undesirable effects

System
Organ Class

Common
Very
Commo ( 1% <
n
10%)
(
10%)

Uncommon
( 0.1% <
1%)

Skin and
Subcutaneous
Tissue
Disorders

4.9

Very Rare
Rare
(
(
0.01%<0.1%) 0.001%<0.01%)

Skin reaction

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC Code: D02A C
Emollients and Protectives
The ingredients provide emollient or 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 that are additional to that
already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Chlorocresol
Cetomacrogol 1000
Cetostearyl alcohol
Isopropyl alcohol
Anhydrous sodium dihydrogen phosphate
Dilute phosphoric acid
Purified water

6.2

Incompatibilities
None known.

6.3

Shelf life
2 years.

6.4

Special precautions for storage
Do not store above 25 C.
Store in the original container.

6.5

Nature and contents of container
Aluminium epoxy-phenolic resin lined tubes with polypropylene screw cap
containing 10 g cream for use as a professional sample only.
Aluminium epoxy-phenolic resin lined tubes with polypropylene screw cap
containing 50 g cream.
HDPE jar with polypropylene screw cap containing 500 g cream.
HDPE bottle with polypropylene pump dispenser containing 500 g cream.

6.6

Special precautions for disposal
No special requirements

7

MARKETING AUTHORISATION HOLDER
QP-Services UK Ltd
Office B, First Floor
57 High Street
Yatton
Somerset
BS49 4EQ
United Kingdom
+44 (0) 1934 838820
info@QP-Services.com

8

MARKETING AUTHORISATION NUMBER(S)
PL 29498/0004

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/11/2007

10

DATE OF REVISION OF THE TEXT
28/01/2013

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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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