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THE 50:50 OINTMENT

Active substance(s): LIQUID PARAFFIN / WHITE SOFT PARAFFIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
The 50:50 Ointment.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient White Soft Paraffin Liquid Paraffin %w/w 50 50

3

PHARMACEUTICAL FORM
Ointment for cutaneous use.

4
4.1

CLINICAL PARTICULARS
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.

Contra-indications 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.

Interactions with other Medicaments 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
5.1

PHARMACOLOGICAL PROPERTIES
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 Characteristics.

6
6.1

PHARMACEUTICAL PARTICULARS
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 25C. 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.

Instruction for Use/Handling No special requirements.

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA United Kingdom

8.

Marketing Authorisation Number PL 00014/0622

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/11/2005

10

DATE OF REVISION OF THE TEXT
18/11/2005

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