Active substance(s): CHLORBUTOL / CLOVE OIL
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clove Oil BP 21.00% w/w, Chlorobutanol BP 7.00 % w/w
Therapeutic indications Temporary relief of toothache.
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.
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.
Special warnings and precautions for use Not applicable.
Interaction with other medicinal products and other forms of interaction Not known.
Fertility, Pregnancy and lactation Not to be used during pregnancy or lactation.
Effects on ability to drive and use machines Not known.
Undesirable effects Not known.
Overdose Not applicable.
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.
Pharmacokinetic properties Not applicable
Preclinical safety data Not applicable
List of excipients De-ionised water, Keltrol RD
Incompatibilities Not applicable
Shelf life 24 Months
Special precautions for storage Store below 25C. Do not freeze
Nature and contents of container 5g Collapsible aluminium tube
Special precautions for disposal Not Applicable
MARKETING AUTHORISATION HOLDER
Optima Consumer Health Ltd Concept house, Brackenbeck Road, Bradford, BD7 2LW, UK
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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