ALCODERM CREAM

Active substance: NOT APPLICABLE

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PRODUCT SUMMARY
1.

NAME OF THE MEDICINAL PRODUCT

Alcoderm Cream

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
None

3.

PHARMACEUTICAL FORM
Cream.

4.

CLINICAL PARTICULARS

4.1

Therapeutic Indications
Dry, chafed or irritated skin - Alcoderm is indicated in any condition where
the moisture content of the horny layer has decreased below the normal level
and the skin is no longer soft and pliable.
Also recommended:
a) in acute inflammatory conditions where the skin is intact, such as sunburn
and windburn.
b) as a soothing, hydrating agent in certain inflammatory skin conditions
where there is dryness and scaling, such as ichthyosis, atopic eczema, winter
itch, etc.

4.2

Posology and Method of Administration
Dosage:
Adults, children and the elderly
Apply topically to the skin as required to alleviate the symptoms of dry,
chafed or irritated skin conditions or as directed by a doctor.

Route of Administration:
Apply topically to the skin.

4.3

Contra-Indications
Hypersensitivity to the constituents of the preparation.

4.4

Special Warnings and Special Precautions for Use
Avoid contact with eyes.
If symptoms persist consult your physician.
In the rare event of a skin reaction, treatment should be discontinued.

4.5

Interactions with other Medicinal Product and other Forms of Interaction
None.

No Data Held
4.6
Pregnancy and Lactation
May be used during this period.

4.7

Effects on Ability to Drive and Use Machines
Not applicable.

4.8

Undesirable Effects
Very rarely, a mild skin irritation can occur.

4.9

Overdose
Accidental ingestion is not anticipated to cause any harm to the patient.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties
Not applicable.

5.2

Pharmacokinetic Properties
Not applicable.

5.3

Pre-clinical Safety Data
Not relevant as the product has been in use for many years without apparent ill
consequence.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of Excipients
Mineral Oil (Liquid Paraffin)
Isopropyl Palmitate Ph. Eur.
Sodium Lauryl Sulphate Ph. Eur.
Methylparaben Ph. Eur.
Propylparaben Ph. Eur.
Sorbitol solution (70%) Ph. Eur.
Cetyl Alcohol Ph. Eur.
Stearyl Alcohol Ph. Eur.
Sorbitan Monostearate Ph. Eur.
Spermaceti (Cetyl Esters Wax) USP/NF
Silicone Fluid (Dimeticone) Ph. Eur.
Perfume (Chemoderm 6435)
Citric Acid Anhydrous Ph. Eur., or Sodium Hydroxide Ph. Eur.
Purified Water Ph. Eur.

6.2

Incompatibilities
None

6.3

Shelf-Life
4 years.

6.4

Special Precautions for Storage
Store at room temperature.

6.5

Nature and Content of Container
Polyethylene plastic tube with a white polypropylene screw cap as the closure.
Package sizes: 60g

6.6

Instruction for Use, Handling and Disposal
Not relevant.

7.

MARKETING AUTHORISATION HOLDER
Galderma (UK) Limited,
Meridien House
69-71 Clarendon Road
Watford
Herts
WD17 1DS
UK

8.

MARKETING AUTHORISATION NUMBER(S)
PL 10590/0004

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
21st January 1993

10

DATE OF REVISION OF THE TEXT
17/07/2006

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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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