White Soft Paraffin Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
White Soft Paraffin BP White Petroleum Jelly BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin BP 100%
3 PHARMACEUTICAL FORM
Ointment
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
To soothe and soften the skin and provide skin protection
4.2 Posology and method of administration
Cutaneous use
For adults, children and the elderly, apply to the affected area 3 times daily until improvement occurs.
4.3 Contraindications
Known hypersensitivity to the ingredient
4.4 Special warnings and precautions for use
Seek advice if symptoms persist.
4.5 Interaction with other medicinal products and other forms of interaction
None
4.6 Fertility, pregnancy and lactation
Acceptable for use during pregnancy and lactation
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
Very rarely, rashes due to hypersensitivity may occur and treatment should then be withdrawn.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.yellowcard.mhra.gov.uk.
4.9 Overdose
If accidentally ingested treat symptomatically.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Helps to soothe irritated skin and soften hardened skin. It can protect against exposure to adverse conditions.
5.2 Pharmacokinetic properties
White soft paraffin is not readily absorbed by the skin.
5.3 Preclinical safety data
None available
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None
6.2 Incompatibilities
None
6.3 Shelf life
60 months in unopened container.
6.4 Special precautions for storage
Protect from light.
6.5 Nature and contents of container
Light resistant plastic jars with plastic or metal screw on caps 45g, 85g, 100g, 120g, 165g, 225g, 250g, 500g, 2000g, 4500g Aluminium tube with polyethylene cap 15g, 25g, 40g, 50g, 80g, 100g, 150g
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Bell, Sons & Co (Druggists) Ltd
Gifford House
Slaidburn Crescent
Southport
Merseyside
PR9 9AL
8 MARKETING AUTHORISATION NUMBER(S)
PL 03105/0042
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31/05/1984 / 26/11/2003
10 DATE OF REVISION OF THE TEXT
15/07/2015