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YELLOW SOFT PARAFFIN BP

Active substance(s): PARAFFIN SOFT YELLOW

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Yellow Soft Paraffin – BP/EP

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Yellow 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 applications.

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.

6.

PHARMACEUTICAL PARTICULARS

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 stored under vacuum and controlled temperatures. Limited quantities
stored in approximately 190kgs. Drums, at ambient temperatures, and away
from direct sunlight, protected from moisture.

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 02021/5001R

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
22 August 1984 I 01 March 1998

10.

DATE OF (PARTIAL) REVISION OF THE TEXT
February 1998

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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