- 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 Fertility, 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
Zinc and Castor Oil Ointment BP or Zinc and Castor Oil Cream BP.
For the full list of excipients, see section 6.1
For relief of the symptoms of nappy rash and as a protective water resistant cream for dry, chapped skin.
Topical. Applied directly to the skin.
Recommended doses and dosage schedules.
As required, up to four times daily or at each nappy change. The product is suitable for use by adults, children and the elderly.
Known hypersensitivity to any of the ingredients listed.
For external use only.
Keep all medicines out of reach and sight of children.
Zinc and Castor Oil Ointment BP contains Arachis Oil (peanut oil) and should not be 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 BP.
Zinc and Castor Oil Cream BP contains Arachis Oil (peanut oil) and should not be 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 Cream BP.
May mask x-ray pictures under certain circumstances.
No information is available on the safety of the product when used during pregnancy and lactation.
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.
Overdosage is unlikely. If accidentally ingested treatment should be symptomatic. Oral ingestion of large quantities of castor oil may cause nausea, vomiting, colic and diarrhoea.
D02AB Emollients and Protectives
Zinc oxide has a mild antiseptic action, and is useful for relieving the symptoms of nappy rash and other minor skin irritations.
The formulation as a whole acts to provide a mildly antiseptic water resistant emollient barrier for dry skin conditions and nappy rash.
No information available.
No data of relevance, which is additional to that included in other sections of the SPC.
White Beeswax (E901)
Refined Arachis Oil
Virgin Castor Oil
36 months unopened.
Store below 25°C.
Styrene crystal jar and polypropylene cap.
Polypropylene jar with lid
Thornton & Ross Ltd
Linthwaite, Huddersfield, West Yorks, HD7 5QH
+44 (0) 1484 848164