TCP Antiseptic Cream

1. Name Of The Medicinal Product

TCP First Aid Antiseptic Cream

2. Qualitative And Quantitative Composition

TCP First Aid Antiseptic Cream contains:

TCP Liquid Antiseptic 25% w/w, Chloroxylenol 0.5% w/w and Triclosan 0.3% w/w. TCP Liquid Antiseptic is an aqueous solution of Phenol 0.175% w/v, halogenated phenols 0.68% w/v and Sodium Salicylate 0.052% w/v.

3. Pharmaceutical Form

Topical cream.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of minor cuts, grazes, scratches, insect bites and stings, spots, pimples and blisters.

TCP First Aid Antiseptic Cream can also be used as a first aid antiseptic hand cream.

Topical administration.

4.2 Posology And Method Of Administration

Adults, children and the elderly:

Minor cuts, grazes, scratches, insect bites and stings:

Clean wound and surrounding skin and apply the cream direct or on to a dressing.

Spots, pimples and blisters:

Apply direct and rub in gently.

TCP First Aid Antiseptic Cream can also be used as a first aid antiseptic hand cream.

4.3 Contraindications

Hypersensitivity to any of the active ingredients.

4.4 Special Warnings And Precautions For Use

If symptoms persist, consult your doctor.

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

There is no experience in the use of the product in pregnancy and lactation, but the product has been widely used for many years with no adverse effects.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Use in allergic skin conditions should be avoided.

4.9 Overdose

TCP First Aid Antiseptic Cream is for topical use only and overdose is considered unlikely.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Halogenated phenols act on all pathogenic micro-organisms similarly and to approximately the same degree i.e. they are non-specific; and their activity is not appreciably reduced by the presence of relatively large amounts of non-living organic matter; their relatively simple chemical constitution means that their use is not liable to encourage the emergence of strains of micro-organisms adapted to resist their action.

5.2 Pharmacokinetic Properties

TCP First Aid Antiseptic Cream is for topical use only. Systemic absorption from this topical dosage form is considered unlikely.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Stearic Acid

Isopropyl Palmitate

Cetyl Alcohol

Cetyl Wax Esters

Glyceryl Monostearate

Sodium Lauryl Sulphate

Carbomer

Glycerol

Sodium Edetate

Potassium Hydroxide

Demineralised Water

Fragrance EAG 5276

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Collapsible aluminium tubes, internally lacquered, fitted with white polyethylene wadless caps.

Tubes of 30g and 60g.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Chefaro UK Ltd.

4th Floor, Hamilton House

Mabledon Place, Bloomsbury

LONDON,

WC1H 9BB

United Kingdom

8. Marketing Authorisation Number(S)

PL 02855/0020

9. Date Of First Authorisation/Renewal Of The Authorisation

16th November 2004

10. Date Of Revision Of The Text

14th November 2010