Zinc & Castor Oil Ointment Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zinc and Castor Oil Ointment BP or Zinc and Castor Oil Cream BP.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc oxide 7.5% w/w.
Virgin castor oil 50.0% w/w.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Ointment.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For relief of the symptoms of nappy rash and as a protective water resistant cream for dry, chapped skin.
4.2. Posology and method of administration
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.
Contraindications
4.3.
Known hypersensitivity to any of the ingredients listed.
4.4. Special warnings and precautions for use
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 an Castor Oil Ointment BP.
or
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.
4.5. Interaction with other medicinal products and other forms of interaction
May mask x-ray pictures under certain circumstances.
4.6. Pregnancy and lactation
No information is available on the safety of the product when used during pregnancy and lactation.
4.7. Effects on ability to drive and use machines
None.
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
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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
Castor oil acts in the formulation as an emollients and helps alleviate dry, hard and chapped skin.
The formulation as a whole acts to provide a mildly antiseptic water resistant emollient barrier for dry skin conditions and nappy rash.
5.2. Pharmacokinetic properties
No information available.
5.3. Preclinical safety data
No data of relevance, which is additional to that included in other sections of the SPC.
PHARMACEUTICAL PARTICULARS
6.
6.1. List of excipients
Cetostearyl Alcohol White Beeswax (E901)
Refined Arachis Oil
6.2. Incompatibilities
None known.
6.3 Shelf life
36 months unopened.
6.4. Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
100g: Styrene crystal jar and polypropylene cap. 500g: Polypropylene jar with lid 6.6. Instructions for use, handling and disposal
None.
7 MARKETING AUTHORISATION HOLDER
L.C.M. Ltd
Linthwaite Laboratories
Huddersfield
HD75QH
England.
MARKETING AUTHORISATION NUMBER
8.
PL 12965/0038
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/10/2005
10 DATE OF REVISION OF THE TEXT
30/12/2014