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The 50:50 Ointment

Last Updated on eMC 04-Apr-2003 View changes  | THE BOOTS COMPANY PLC Contact details

1. Name of the medicinal product

The 50:50 Ointment.

2. Qualitative and quantitative composition

Active ingredient

%w/w

White Soft Paraffin

50

Liquid Paraffin

50

3. Pharmaceutical form

Ointment for cutaneous use.

4. Clinical particulars
4.1 Therapeutic indications

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

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.

4.3 Contraindications

Hypersensitivity to either White Soft Paraffin or Liquid Paraffin.

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.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.

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.

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.

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.

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

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

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.

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.

6. Pharmaceutical particulars
6.1 List of excipients

Not applicable.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Polypropylene jar with unlined polyethylene cap

Pack size: 500g.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

The Boots Company

1 Thane Road

Nottingham

NG2 3AA

8. Marketing authorisation number(s)

PL 00014/0622

9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text

July 2000

Company contact details

THE BOOTS COMPANY PLC

Company image
Address

1 Thane Road West, Beeston, Nottingham, NG2 3AA

Fax

+44 (0)1159 592 565

Telephone

+44 (0)1159 595 165

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?

Active ingredients

liquid paraffin, white soft paraffin

Legal categories

P - Pharmacy

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