ZINC AND CASTOR OIL OINTMENT BP (Ecolab)

1. Name Of The Medicinal Product

ZINC AND CASTOR OIL OINTMENT BP

2. Qualitative And Quantitative Composition

Zinc Oxide BP 7.5% w/w

3. Pharmaceutical Form

Ointment.

4. Clinical Particulars

4.1 Therapeutic Indications

An emollient and astringent.

4.2 Posology And Method Of Administration

This product is used as an emollient and astringent for topical application to the skin.

4.3 Contraindications

Do not use in patients who are hypersensitive to any of the ingredients.

4.4 Special Warnings And Precautions For Use

For external use only. Keep out of the reach and sight of children.

Zinc and Castor Oil Ointment contains Arachis oil (peanut oil) and should not be taken/applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Zinc and Castor Oil Ointment.

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not applicable.

4.6 Pregnancy And Lactation

No contraindications known.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Skin sensitivity reactions may rarely occur.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Zinc Oxide has a mild astringent action and provides a soothing and protecting effect.

Castor Oil has an emollient effect.

5.2 Pharmacokinetic Properties

Not applicable, topical application.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetostearyl Alcohol BP

Castor Oil BP

Arachis Oil BP

White Beeswax BP

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

500g and 100g HDPE containers, 50g, 30g and 15g aluminium tubes.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0044

9. Date Of First Authorisation/Renewal Of The Authorisation

1 May 2003 / January 2004

10. Date Of Revision Of The Text

August 2006