Tcp First Aid Antiseptic Cream
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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.
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.
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 nonliving organic matter; their relatively simple chemical constitution means that their use is not liable to encourage the emergence of strains of microorganisms 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
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road LONDON, SW1V 2SA 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
18/07/2014