This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Find out more here.

eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
New eMC coming June 2013...

THE BOOTS COMPANY PLC

1 Thane Road West, Beeston, Nottingham, NG2 3AA
Telephone: +44 (0)1159 595 165
Fax: +44 (0)1159 592 565

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?


Summary of Product Characteristics last updated on the eMC: 04/04/2003
SPC The 50:50 Ointment


Go to top of the page
1. Name of the medicinal product

The 50:50 Ointment.


Go to top of the page
2. Qualitative and quantitative composition

Active ingredient

%w/w

White Soft Paraffin

50

Liquid Paraffin

50


Go to top of the page
3. Pharmaceutical form

Ointment for cutaneous use.


Go to top of the page
4. Clinical particulars

Go to top of the page
4.1 Therapeutic indications

For general use as an emollient in the symptomatic relief of dry skin conditions.


Go to top of the page
4.2 Posology and method of administration

Adults, Children and the Elderly.

Apply a thin film of the ointment to the affected area of the skin, in the direction of hair growth, as required. Repeat as necessary. Ideally the product should be applied three or four times a day, or at least twice a day.

In adults, where a large area of the body is affected, up to 500g a week may be used.

For topical administration.


Go to top of the page
4.3 Contraindications

Hypersensitivity to either White Soft Paraffin or Liquid Paraffin.


Go to top of the page
4.4 Special warnings and precautions for use

The ointment should be applied in the direction of hair growth to reduce the incidence of folliculitis.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.


Go to top of the page
4.6 Pregnancy and lactation

The safety of White Soft Paraffin and Liquid Paraffin during pregnancy and lactation has not been established, but use during these periods is not considered to constitute a hazard.


Go to top of the page
4.7 Effects on ability to drive and use machines

The ointment is greasy and if applied to the hands, appropriate care should be taken if driving or operating machinery.


Go to top of the page
4.8 Undesirable effects

Rarely hypersensitivity reactions. Prolonged use of large quantities may cause folliculitis, should this occur, use of the product should be discontinued.


Go to top of the page
4.9 Overdose

The 50:50 ointment is of low toxicity and if ingested treatment should be supportive and symptomatic. Gastric lavage should not be attempted following ingestion of paraffin-based products, due to the risk of inhalation or aspiration into the lungs.


Go to top of the page
5. Pharmacological properties

Go to top of the page
5.1 Pharmacodynamic properties

White Soft Paraffin and Liquid Paraffin are emollients with occlusive properties for topical application.


Go to top of the page
5.2 Pharmacokinetic properties

There is no significant systemic absorption of the active ingredients. Following topical application, not all the product remains on the skin surface and there is substantial penetration into the stratum corneum.


Go to top of the page
5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product of Characteristics.


Go to top of the page
6. Pharmaceutical particulars

Go to top of the page
6.1 List of excipients

Not applicable.


Go to top of the page
6.2 Incompatibilities

Not applicable.


Go to top of the page
6.3 Shelf life

24 months.


Go to top of the page
6.4 Special precautions for storage

Do not store above 25oC. Store in the original container. Stir well if separation occurs.


Go to top of the page
6.5 Nature and contents of container

Polypropylene jar with unlined polyethylene cap

Pack size: 500g.


Go to top of the page
6.6 Special precautions for disposal and other handling

No special requirements.


Go to top of the page
7. Marketing authorisation holder

The Boots Company

1 Thane Road

Nottingham

NG2 3AA


Go to top of the page
8. Marketing authorisation number(s)

PL 00014/0622


Go to top of the page
9. Date of first authorisation/renewal of the authorisation

Go to top of the page
10. Date of revision of the text

July 2000



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/12002/SPC/


Active Ingredients/Generics