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SOOTHAKE GEL

Active substance(s): CHLORBUTOL / CLOVE OIL / CHLORBUTOL / CLOVE OIL / CHLORBUTOL / CLOVE OIL

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SUMMARY OF PRODUCT CHARACTERISTICS

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
4.1

CLINICAL PARTICULARS
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 Not applicable.

5
5.1

PHARMACOLOGICAL PROPERTIES
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 Not applicable

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients De-ionised water, Keltrol RD

6.2

Incompatibilities Not applicable

6.3

Shelf life 24 Months

6.4

Special precautions for storage Store below 25C. 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

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/05/2008

10

DATE OF REVISION OF THE TEXT
31/07/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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