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SOOTHAKE TOOTHACHE TINCTURE

Active substance(s): CLOVE OIL / LIDOCAINE HYDROCHLORIDE / CLOVE OIL / LIDOCAINE HYDROCHLORIDE / CLOVE OIL / LIDOCAINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Soothake Toothache Tincture

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine Hydrochloride BP 0.70 % w/w
Clove Oil BP l0.00%w/w

3

PHARMACEUTICAL FORM
Topical local anaesthetic liquid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
A first aid treatment for the temporary relief of toothache caused by dental
cavity.

4.2

Posology and method of administration
Dip a clean cotton bud into the product and apply to the dental cavity in the
aching tooth.

4.3

Contraindications
Contraindicated in patients hypersensitive to any of the ingredients or for
dental pain other than that caused by cavities e.g. gum infections.

4.4

Special warnings and precautions for use
Keep out of reach of children.
Toothache Tincture is only intended as a First Aid measure avoid prolonged
use.
Consult a doctor as soon as possible.

4.5

Interaction with other medicinal products and other forms of interaction
None known

4.6

Fertility, Pregnancy and lactation
Not applicable

4.7

Effects on ability to drive and use machines
Not applicable

4.8

Undesirable effects
Hypersensitivity reactions to any of the ingredients have been reported rarely.
Excessive contact with the gums or lips may cause ulceration.

4.9

Overdose
Accidental oral ingestion of clove oil may lead to CNS depression, urinary
abnormalities, anion gap acidosis, deterioration of liver function, coma,
seizure and low blood glucose levels. Treatment should be supportive and
symptomatic; there have been reports in the literature that N-acetylcysteine
has been successfully used as an antidote.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Lidocaine Hydrochloride is a local anaesthetic. It is widely used as a local
anaesthetic in dentistry. Clove Oil has along history of use as a domestic
remedy for toothache.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Ethanol 96% (Alcohol)

6.2

Incompatibilities
None Known

6.3

Shelf life
36 months

6.4

Special precautions for storage
Do not store above 25 C. Do not freeze.

6.5

Nature and contents of container
Brown glass vial with screw top containing 10ml

6.6

Special precautions for disposal
Keep out of reach of children.
Dip a clean cotton bud into the product and apply to the dental cavity in the
aching tooth

7

MARKETING AUTHORISATION HOLDER
Optima Consumer Health Ltd
Concept house,
Brackenbeck Road,
Bradford,
BD7 2LW,
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 40575/0008

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/04/2005

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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