White Soft Paraffin Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
White Soft Paraffin - BP.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin - BP 100% w/w.
3. PHARMACEUTICAL FORM
Soft Paraffin.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
For use as a base for ointment preparation and for topical application.
4.2. Posology and Method of Administration
Not applicable.
4.3 Contra-Indications
Not applicable.
4.4. Special Warnings and Special Precautions for Use
Not applicable.
4.5.
Interaction with other Medicinal Products and other Forms of Interaction
Not applicable.
4.6. Pregnancy and Lactation
Not applicable.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8. Undesirable Effects
Not applicable.
4.9. Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Not applicable.
5.2. Pharmacokinetic Properties
Not applicable.
5.3. Pre-clinical Safety Data
Not applicable.
PHARMACEUTICAL PARTICULARS
6.
6.1. List of Excipients
Product is 100% an excipient.
6.2. Incompatibilities
None.
6.3. Shelf-Life
24 months.
6.4. Special Precautions for Storage
Bulk stores under vacuum and controlled temperatures. Limited quantities stored in approximately 190kgs. Drum, at ambient temperatures, under dry conditions and away from direct sunlight.
6.5. Nature and Contents of Container
Bulk up to 20 tonnes, 190 kgs. Drums, 12.5 & 50 kgs. kegs, 3 & 5 kgs container.
6.6. Instructions for Use/Handling
No special instructions.
7 MARKETING AUTHORISATION HOLDER
Fuchs Lubricants (UK) Plc New Century Street Hanley
Stoke on Trent ST1 5HU
8. MARKETING AUTHORISATION NUMBER(S)
PL 02021/5000R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
22 August 1984 I 1 March 1998
10. DATE OF (PARTIAL) REVISION OF THE TEXT
February 1998