ICHTHYOL-GESELLSCHAFT |
1. Name of the medicinal product
1. Name of the medicinal product
ICHTHOSIN® cream
Active ingredient: sodium bituminosulfonate, pale
2. Qualitative and quantitative composition
Active ingredients
Each 100 g ICHTHOSIN® cream contain:
Active ingredient: sodium bituminosulfonate (ICHTHYOL® sodium), pale 4.0 g
Other excipients: propylene glycol and cetyl alcohol
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Cream
4. Clinical particulars
4.1 Therapeutic indications
Treatment of light forms of atopic eczema as well as other types of dermatitis.
4.2 Dosage and method of administration
ICHTHOSIN® cream is thinly applied three times a day to the disease skin areas. The treatment can be continued until the symptoms have disappeared. Treatment should not be continued for more than 4 weeks.
4.3 Contraindications
Established hypersensitivity to sulphonated shale oils or to any of the excipients.
4.4 Special warnings and precautions for use
Contact with the eyes has to be avoided. Propylene glycol can cause skin irritations. Cetyl alcohol can cause locally limited skin irritations (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction
The concomitant use of other scalp therapeutic agents may impair the effect of ICHTHOSIN® cream.
4.6 Pregnancy and lactation
No data are available about the use of ICHTHOSIN® cream in humans during pregnancy and lactation. The data obtained from animal studies are unsufficient. The potential risk of the use of this product by pregnant women and nursing mothers is unkown.
4.7 Effects on ability to drive and use machines
ICHTHOSIN® cream has no influence on the ability to drive and use machines.
4.8 Undesirable effects
The evaluation of side-effects is based on the following incidence rates:
very frequently (≥ 1/10)
frequently (≥ 1/100 to < 1/10)
occasionally (≥ 1/1,000 to < 1/100)
rarely (≥ 1/10,000 to < 1/1,000)
very rarely (< 1/10,000)
Skin irritations or allergic irritations may occur in individual cases (< 0.01 %) (e.g. skin redness, itching of the skin).
4.9 Overdose
Not applicable.
6. Pharmaceutical particulars
6.1 List of excipients
Propylene glycol, glycerol stearate, cetyl alcohol, medium-chain triglycerides, PEG-20-glycerol monostearate, petrolatum, agua
6.2 Incompatibilities
Pale sodium bituminosulfonate can solubilize other active substances and enhance their absorption through the skin. Precipitation may occur after addition of highly concentrated acids and salts.
6.3 Shelf life
3 years.
Do not use this product after expiry date.
6.4 Special precautions for storage
ICHTHOSIN® should not be kept at temperatures exceeding 30° C.
6.5 Nature and contents of container
Tube containing 25 g of cream, 50 g of cream.
6.6 Special precautions for disposal
No special requirements.
7. Marketing authorisation holder
ICHTHYOL-GESELLSCHAFT
Cordes, Hermanni & Co. (GmbH & Co.) KG
Sportallee 85
22335 Hamburg
Tel: +49 40/50714-0
Fax: +49 40/50714-110
eMail: info[at]ichthyol.de