Emulsifying Ointment Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emulsifying Ointment BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin BP 50.0% w/w Emulsifying Wax BP 30.0% w/w Liquid Paraffin BP 20.0% w/w
3 PHARMACEUTICAL FORM
Ointment
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As an emollient in the management of dry skin including chronic eczema, as a soap substitute and as a vehicle for medications.
4.2 Posology and method of administration
For External use only
Adults (including the elderly) and Children
Apply to the affected area 1 to 3 times daily until an improvement occurs
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
For External use only Store below 25 °C Keep well closed.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, Pregnancy and lactation
There is no evidence of hazard to suggest that this product should not be used in pregnancy and lactation.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Very rarely hypersensitivity reactions may occur.
4.9 Overdose
If accidentally ingested, nausea, vomiting and diarrhoea may occur. Treatment should be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The ingredients have an emollient effect. They soothe and hydrate the skin by acting as a barrier.
5.2 Pharmacokinetic properties
Liquid paraffin is absorbed to a slight extent. Soft Paraffin and Emulsifying Wax are not readily absorbed. They have no systemic effect.
5.3 Preclinical safety data
None stated
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
None
6.2 Incompatibilities
None stated
6.3 Shelf life
3 Years
6.4 Special precautions for storage
Store below 25° C Keep well closed.
6.5 Nature and contents of container
Plastic containers and lids 500g
6.6 Special precautions for disposal
None Stated
7 MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas,
PC. 1060 Nicosia.
Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 28444/0134
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13/03/2013
10 DATE OF REVISION OF THE TEXT
11/10/2013