Care Antiseptic First Aid Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Care Antiseptic First Aid Cream Sainsbury’s Antiseptic First Aid Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Cetrimide 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. Contra-Indications
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. Avoid contact with eyes. For external use only; not for use in body cavities.
Antiseptic First Aid Cream contains the excipients cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and chlorocresol which may cause allergic reactions.
Labels to state: FOR EXTERNAL USE ONLY.
Keep out of the reach and sight 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
Skin irritation and occasionally sensitisation.
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
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. Demulcents and diluents may be given if necessary but emesis and lavage should be avoided. Activated charcoal may be considered if the patient presents within an hour of ingestion.
PHARMACOLOGICAL PROPERTIES
5.
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. Pre-clinical Safety Data
None.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cetostearyl Alcohol, Liquid Paraffin, Chlorocresol, Purified Water.
6.2. Incompatibilities
Cetrimide is incompatible with soaps and other anionic surfactants, Bentonite, Iodine, Phenylmercuric Nitrate and Alkali Hydroxides.
6.3 Shelf Life
30 months (unopened)
6.4. Special Precautions for Storage
Store below 25°C. Do not allow to freeze.
6.5 Nature and contents of container
30g lacquered aluminium tube and cap
6.6. Instructions for Use, Handling and Disposal
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
19/11/2010
10 DATE OF REVISION OF THE TEXT
24/11/2014