Tcp Antiseptic Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TCP™ Antiseptic Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TCP Antiseptic Ointment contains:
TCP Liquid Antiseptic 6.4% w/w, Iodine 0.2 1% w/w, Methyl Salicylate 1.33% w/w, Precipitated Sulphur 1.5% w/w, Tannic Acid 1973 0.4% w/w, Camphor 1.31% w/w and Salicylic Acid 0.4% 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.
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
Topical Ointment.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For piles, embarrassing irritation (pruritus), cuts, grazes, minor wounds and skin irritation, minor burns and scalds, insect bites and stings and spots and pimples.
4.2 Posology and method of administration
For topical administration.
Adults, children and the elderly
Piles: Apply freely night and morning to affected area which has been gently cleansed. Persons suffering from piles are advised to consult a doctor.
Pruritus: When local itching occurs, cleanse affected area thoroughly then apply the ointment freely. For anal pruritus the ointment is best applied after defaecation.
Cuts, grazes, minor wounds and skin irritation: Cleanse the area thoroughly with warm water then apply ointment, preferably on a piece of lint or gauze.
Minor burns and scalds: Apply the ointment promptly and freely: repeat as required.
Spots and pimples: Cleanse skin thoroughly with hot water. Apply the ointment thinly morning and evening.
Insect bites and stings: Apply the ointment at once. Repeat as required.
4.3 Contraindications
Hypersensitivity to any of the active ingredients.
Use in allergic skin conditions should be avoided.
4.4 Special warnings and precautions for use
If symptoms persist, consult your doctor.
For external use only.
Keep medicines 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 over many years with no reported adverse effect.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
None stated.
4.9 Overdose
TCP Antiseptic Ointment is for topical use only and overdose is considered to be very 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 Antiseptic Ointment is for topical use only. Systemic absorption from this topical dosage form is considered unlikely.
5.3 Preclinical safety data
No data applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Potassium Iodide
Clove Oil
Citric Acid Powder Disodium Edetate Glycerol Kaolin light Hydrochloric acid Demineralised Water Yellow soft paraffin
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, fitted with white polythene screw caps.
Tubes of 14g and 30g.
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 02855/0019
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16/10/1984 / 05/01/2007
10 DATE OF REVISION OF THE TEXT
18/07/2014