ICHTHYOL-GESELLSCHAFT |
1. Name of the medicinal product
1. Name of the medicinal product
ICHTHODERM® cream
Active ingredient: sodium bituminosulfonate, pale
2. Qualitative and quantitative Composition
Each 100 g ICHTHODERM® cream contain:
Active ingredient: Sodium bituminosulfonate (sodium ICHTHYOL®), pale 2.0 g
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Cream
4. Clinical particulars
4.1 Therapeutic indications
Seborrhoea oleosa and sicca of the scalp, psoriasis of the scalp, eczema, Pruritus and Folliculitis of the scalp
4.2 Dosage and method of administration
ICHTHODERM® cream is applied to the moistened scalp, lightly rubbed in, and rinsed out with warm water after allowing it to take effect for 2 to 3 minutes. Subsequently, the treatment is repeated allowing the cream to take effect for at least 5 minutes. If required, the time of exposure can be expanded to several hours. Also, the cream can be allowed to take effect over night after single application. The frequency of application depends on the clinical picture and recurrence of dandruff and itching. During the first two weeks, ICHTHODERM® cream is applied several times a week; with a progressive regression of the disease, application once a week is usually sufficient.
The duration of application depends on the result of the treatment.
4.3 Contraindications
Established hypersensitivity to sulphonated shale oils or to any of the excipients.
4.4 Special warning and precautions for use
Do not apply directly in the eye. In the event of contact with the eyes, wash out with water; if necessary, a symptomatic treatment should be carried out.
Propylene glycol may cause skin irritation.
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 ICHTHODERM® cream.
4.6 Pregnancy and lactation
With the normal therapeutic dosages, there is no evidence of any risk of application for human beings or animals. Medicinal products during pregnancy and lactation should be only used after accurate diagnosis.
4.7 Effects on ability to drive and use machines
ICHTHODERM® 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)
Intolerance reactions of the skin may occur in very rare cases (< 0.01 %). In individual cases contact allergies may occur.
4.9 Overdose
Not applicable.
6. Pharmaceutical particulars
6.1 List of excipients
Octyldodecanol, poloxamer 407, propylene glycol, purified water
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
4 years
This medicinal product should not be used after expiration date.
6.4 Special precautions for storage
None
6.5 Nature and contents of container
Original packages:
Tube containing 25 g of cream and 50 g of cream.
6.6 Instructions for use and handling
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