- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
The 50:50 Ointment.
2. Qualitative and quantitative composition
|White Soft 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.
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.
Reporting of suspected adverse reactionsReporting 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.mhra.gov.uk/yellowcard.
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
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25°C. 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 Company1 Thane RoadNottinghamNG2 3AA
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
29 September 2015
THE BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA
+44 (0)1159 592 565
+44 (0)1159 595 165