Care Antiseptic First Aid Cream: Clinical Particulars

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

Excipient(s) with known effects:

Cetostearyl alcohol 5% w/w

Chlorocresol 0.1% w/w

For a full list of excipients see section 6.1

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. Avoid contact with eyes. For external use only; not for use in body cavities.

Excipient warnings:

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 sight and 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

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.

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, 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 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

Thornton & Ross Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH.

8. Marketing authorisation number

PL 00240/6277R

9. Date of first authorisation/renewal of the authorisation

19/11/2010

10. Date of revision of the text

19/10/2020