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