Summary of medicine characteristics - SOOTHAKE GEL
1 NAME OF THE MEDICINAL PRODUCT
Soothake Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clove Oil BP 21.00% w/w,
Chlorobutanol BP 7.00 % w/w
3 PHARMACEUTICAL FORM
Gel.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Temporary relief of toothache.
4.2 Posology and method of administration
Route of Administration: Topical
Adults Only: Squeeze a small amount of gel onto a clean finger. Place into cavity in the tooth.
4.3 Contraindications
Always apply Soothacke sparingly.
The preparation is intended for the temporary relief of toothache.
Consult a Dentist as soon as possible.
Do not use continuously.
Keep out of reach of children.
4.4 Special warnings and precautions for use Not applicable.
4.5 Interaction with other medicinal products and other forms of interaction Not known.
4.6 Fertility, Pregnancy and lactation
Not to be used during pregnancy or lactation.
4.7 Effects on ability to drive and use machines Not known.
4.8 Undesirable effects
Not known.
4.9 Overdose
4.9 OverdoseNot applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Clove Oil BP is a traditional remedy for relief of toothache and is slightly analgesic.
Chlorobutanol BP is antimicrobial, antifungal and acts as a local anaesthetic.
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
5.3 Preclinical safety dataNot applicable
6 PHARMACEUTICAL PARTICULARS
6 PHARMACEUTICAL PARTICULARS6.1 List of excipients De-ionised water, Keltrol RD
6.2 Incompatibilities
Not applicable
6.3 Shelf life
6.3 Shelf life24 Months
6.4 Special precautions for storage
Store below 25°C. Do not freeze
6.5 Nature and contents of container
5g Collapsible aluminium tube
6.6 Special precautions for disposal
Not Applicable
7 MARKETING AUTHORISATION HOLDER
Optima Consumer Health Ltd
Concept house,
Brackenbeck Road,
Bradford,
BD7 2LW,
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 40575/0007