Active substance(s): NOT APPLICABLE
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
a) in acute inflammatory conditions where the skin is intact, such as sunburn
b) as a soothing, hydrating agent in certain inflammatory skin conditions
where there is dryness and scaling, such as ichthyosis, atopic eczema, winter
Posology and Method of Administration
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.
Hypersensitivity to the constituents of the preparation.
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.
Interactions with other Medicinal Product and other Forms of Interaction
No Data Held
Pregnancy and Lactation
May be used during this period.
Effects on Ability to Drive and Use Machines
Very rarely, a mild skin irritation can occur.
Accidental ingestion is not anticipated to cause any harm to the patient.
Pre-clinical Safety Data
Not relevant as the product has been in use for many years without apparent ill
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.
Special Precautions for Storage
Store at room temperature.
Nature and Content of Container
Polyethylene plastic tube with a white polypropylene screw cap as the closure.
Package sizes: 60g
Instruction for Use, Handling and Disposal
MARKETING AUTHORISATION HOLDER
Galderma (UK) Limited,
69-71 Clarendon Road
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
21st January 1993
DATE OF REVISION OF THE TEXT