1. Name Of The Medicinal Product
Cetrimide Cream BP
Care Antiseptic First Aid Cream
Sainsburys Antiseptic First Aid Cream
2. Qualitative And Quantitative Composition
Contains Cetrimide BP 0.5% w/w as active ingredient.
3. Pharmaceutical Form
Cream.
4. Clinical Particulars
4.1 Therapeutic Indications
For use in minor burns, napkin rash and abrasions.
4.2 Posology And Method Of Administration
Topical: Apply directly to the affected part.
This product is suitable for adults, children, and the elderly.
4.3 Contraindications
Contra-indicated in patients with known hypersensitivity to cetrimide.
4.4 Special Warnings And Precautions For Use
Prolonged and repeated applications of cetrimide to the skin may lead to hypersensitivity.
Labels to state: FOR EXTERNAL USE ONLY.
Keep out of reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
No information is available on the safety or use of the product in the above conditions.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
None known.
4.9 Overdose
Overdose by the recommended route of administration is considered unlikely. Ingestion may cause nausea and vomiting. Toxic symptoms include dyspnoea and cyanosis, possibly leading to asphyxia. Depression of the central nervous system, hypotension and coma may also occur.
Treatment of poisoning is symptomatic. Emesis and lavage should be avoided.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Cetrimide is a quaternary ammonium cationic disinfectant with bactericidal activity against gram-positive and some gram-negative organisms. Cetrimide is relatively ineffective against viruses.
5.2 Pharmacokinetic Properties
No information available.
5.3 Preclinical Safety Data
None.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Cetostearyl Alcohol BP, Liquid Paraffin BP, Chlorocresol BP, Purified Water BP.
6.2 Incompatibilities
Cetrimide is incompatible with soaps and other anionic surfactants, Bentonite, Iodine, Phenylmercuric Nitrate and Alkali Hydroxides.
6.3 Shelf Life
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6.4 Special Precautions For Storage
Store below 25°C. Do not allow to freeze.
6.5 Nature And Contents Of Container
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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: 00240/6277R.
9. Date Of First Authorisation/Renewal Of The Authorisation
10.02.87 / 10.02.92, 25.06.98.
10. Date Of Revision Of The Text
31.08.2008
11 DOSIMETRY (IF APPLICABLE)
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Not Applicable
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