This information is intended for use by health professionals

1. Name of the medicinal product

Cetomacrogol Cream BP 1988 Formula A

2. Qualitative and quantitative composition

Macrogol Cetostearyl Ether 22 1.8% w/w

3. Pharmaceutical form

Cream.

4. Clinical particulars
4.1 Therapeutic indications

For external application for use as an emollient, and for use as a diluent in medicinal external preparations.

4.2 Posology and method of administration

Topical

Recommended dose and dosage schedule

To be used as prescribed by a registered medical practitioner or counter prescribed by a registered pharmacist.

The product is suitable for use by adults, children and the elderly.

Dosage: as prescribed by the medical practitioner or pharmacist.

4.3 Contraindications

Sensitivity to chlorocresol.

4.4 Special warnings and precautions for use

For external use only.

Keep all medicines away from children.

Store below 25°C. Do not allow to freeze.

The diluted cream should be used within 2 weeks of preparation.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

No special precautions regarding this vehicle.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

None known.

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.mhra.gov.uk/yellowcard.

4.9 Overdose

Not applicable.

5. Pharmacological properties
5.1 Pharmacodynamic properties

The product has an emollient effect.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

None.

6. Pharmaceutical particulars
6.1 List of excipients

Cetostearyl Alcohol

Chlorocresol

Liquid Paraffin

Paraffin White Soft

Water Purified

6.2 Incompatibilities

Macrogol cetostearyl ether is incompatible with phenols and reduces the antibacterial activity of quaternary ammonium compounds.

6.3 Shelf life

500g: 36 months unopened.

6.4 Special precautions for storage

Store below 25°C. Do not allow to freeze.

6.5 Nature and contents of container

500g: polypropylene jar and lid.

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

Thornton & Ross Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing authorisation number(s)

PL 00240/0014

9. Date of first authorisation/renewal of the authorisation

31.05.74 / Last renewed 25.11.98

10. Date of revision of the text

26/11/2014