- Approval Id
- acad6992b82197ef
- Drug Approval Emc Name
- Dentinox Teething Gel
- Drug Name
- Dentinox Teething Gel
- Company Name
- Dendron Brands Limited
- Company Address
- 94 Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ
- Company Website
- http://www.dddgroup.co.uk
- Company Telephone
- +44 (0)1923 229251
- Company Medical Info Direct Line
- +44 (0)1923 204492
- Company Medical Info Email
- customerdesk@dddltd.co.uk
- Company Customer Care Direct Line
- +44 (0)1923 229251
- Company Medical Info Fax
- +44 (0)1923 220728
- Atc Code
- A01AD
- Legal Category
- Pharmacy
- Authorisation Holder
- Dendron Brands Limited,
94, Rickmansworth Road,
Watford,
Hertfordshire,
United Kingdom,
WD18 7JJ.
- Authorisation Number
- PL 52731/0006
- Authorisation Date
- 19/01/2007
- Instruction Authorisation Holder
- Dendron Brands Limited,
94, Rickmansworth Road,
Watford,
Hertfordshire,
United Kingdom,
WD18 7JJ.
- Instruction Authorisation Number
- PL 52731/0006
- Instruction Authorisation Date
- 19/01/2007
- Instruction Composition
- Lidocaine Hydrochloride BP 0.33 % w/w
Cetylpyridinium Chloride BP 0.10 % w/w
For full list of excipients, see section 6.1.
- Instruction Dosage Form
- Dental gel
Greenish yellow brown gel.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For relief of pain and discomfort associated with teething in children from 5 months of age, where non-pharmacological treatments have failed to provide sufficient relief.4.2 Posology and method of administration
Apply a pea-sized amount (0.2 grams) of Dentinox Teething Gel with a clean finger to the affected area of gum.
The dose may be repeated if necessary after 3 hours, up to a maximum of 6 doses in 24 hours.
Treatment should be stopped once symptoms have resolved.
Not to be used for more than 7 days.
Parents or carers should seek medical attention if the child's condition deteriorates during treatment.
In case of vomiting, spitting or accidental ingestion, the dose should not be repeated immediately. The dose may be repeated if necessary after 3 hours.4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.4.4 Special warnings and precautions for use
Keep all medicines out of sight and reach of children. Do not use if seal on nozzle is broken.
Do not use more than one product containing lidocaine at the same time.4.5 Interaction with other medicinal products and other forms of interaction
None Known.4.6 Pregnancy and lactation
Not applicable.4.7 Effects on ability to drive and use machines
Not applicable.4.8 Undesirable effects
None Known.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.4.9 Overdose
We are not aware of any problems caused by overdosage.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Stomatological Preparation, ATC code: A01AD
Cetylpyridium Chloride is a cationic disinfectant which is used for minor wounds, treating superficial infections of the mouth and preserving the product.
Lidocaine Hydrochloride is a local anaesthetic. It works by blocking nerve conduction when applied topically to nerve tissue. It acts on any part of the nervous system and on every type of nerve fibre. For example, when it is applied to the motor cortex, impulse transmission from that area stops, and when it is injected into the skin it prevents the initiation and the transmission of the sensory impulses. A local anaesthetic in contact with a nerve trunk can cause both sensory and motor paralysis in the area innervated. Many kinds of compounds interfere with conduction, but they often permanently damage the nerve cells. The great practical advantage of the local anaesthetics is that their use is reversible, their use is followed by complete recovery in nerve function with no evidence of structural damage to nerve fibres or cells.5.2 Pharmacokinetic properties
Lidocaine produces more prompt, more intense, longer-lasting and more intense anaesthesia than does an equal concentration of procaine. Unlike procaine it is an aminoethylamide. It is an agent of choice, therefore, in individuals sensitive to ester-type local anaesthetics. Lidocaine is relatively quickly absorbed. Lidocaine is metabolised in the liver by mixed-function oxidases by dealkylation to monoethyl glycine and xylidide. The latter compound retains significant local anaesthetic and toxic activity. In man about 75% of xylidide is excreted in the urine as the further metabolite 4-hydroxy-2,6-dimethylaniline. The typical dose of Dentinox gel is about 150mg containing about 0.5mg of lidocaine hydrochloride (which approximates to about 0.1 mg/kg of bodyweight). Martindale recommends that the total dose of lidocaine hydrochloride should not exceed 200mg (3mg per kg of bodyweight). Thus, the dosage of Dentinox Gel is well within this level.5.3 Preclinical safety data
Not applicable.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
| | |
| --- | --- |
| Purified Water BP | 43.34 % w/w |
| Sorbitol Solution 70 % (non-crystallising) BP | 21.00 % w/w |
| Xylitol HSE | 14.00 % w/w |
| Ethanol 96% BP | 9.36 % w/w |
| Glycerol BP | 7.00 % w/w |
| Hydroxethylcellulose BP | 2.50 % w/w |
| Polyoxyl 40 hydrogenated castor oils | 1.00 % w/w |
| Pharmaceutical Liquid Flavour | 0.48 % w/w |
| Hydroxypolyethoxy Dodecane | 0.33 % w/w |
| Macrogol 300 | 0.33 % w/w |
| Sodium Saccharin | 0.10 % w/w |
| Caramel E150 | 0.07 % w/w |
| Levomenthol | 0.06 % w/w |6.2 Incompatibilities
None Known.6.3 Shelf life
3 years6.4 Special precautions for storage
Do not store above 25°C6.5 Nature and contents of container
Internally lacquered aluminium tube, the nozzle of which contains a membrane.
Pack size 10g (tube), 1 g sachet
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
- Instruction Content
- ## Composition
Lidocaine Hydrochloride BP 0.33 % w/w
Cetylpyridinium Chloride BP 0.10 % w/w
For full list of excipients, see section 6.1.
## Pharmaceutical Form
Dental gel
Greenish yellow brown gel.
## Clinical Particulars
4.1 Therapeutic indications
For relief of pain and discomfort associated with teething in children from 5 months of age, where non-pharmacological treatments have failed to provide sufficient relief.4.2 Posology and method of administration
Apply a pea-sized amount (0.2 grams) of Dentinox Teething Gel with a clean finger to the affected area of gum.
The dose may be repeated if necessary after 3 hours, up to a maximum of 6 doses in 24 hours.
Treatment should be stopped once symptoms have resolved.
Not to be used for more than 7 days.
Parents or carers should seek medical attention if the child's condition deteriorates during treatment.
In case of vomiting, spitting or accidental ingestion, the dose should not be repeated immediately. The dose may be repeated if necessary after 3 hours.4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.4.4 Special warnings and precautions for use
Keep all medicines out of sight and reach of children. Do not use if seal on nozzle is broken.
Do not use more than one product containing lidocaine at the same time.4.5 Interaction with other medicinal products and other forms of interaction
None Known.4.6 Pregnancy and lactation
Not applicable.4.7 Effects on ability to drive and use machines
Not applicable.4.8 Undesirable effects
None Known.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.4.9 Overdose
We are not aware of any problems caused by overdosage.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Stomatological Preparation, ATC code: A01AD
Cetylpyridium Chloride is a cationic disinfectant which is used for minor wounds, treating superficial infections of the mouth and preserving the product.
Lidocaine Hydrochloride is a local anaesthetic. It works by blocking nerve conduction when applied topically to nerve tissue. It acts on any part of the nervous system and on every type of nerve fibre. For example, when it is applied to the motor cortex, impulse transmission from that area stops, and when it is injected into the skin it prevents the initiation and the transmission of the sensory impulses. A local anaesthetic in contact with a nerve trunk can cause both sensory and motor paralysis in the area innervated. Many kinds of compounds interfere with conduction, but they often permanently damage the nerve cells. The great practical advantage of the local anaesthetics is that their use is reversible, their use is followed by complete recovery in nerve function with no evidence of structural damage to nerve fibres or cells.5.2 Pharmacokinetic properties
Lidocaine produces more prompt, more intense, longer-lasting and more intense anaesthesia than does an equal concentration of procaine. Unlike procaine it is an aminoethylamide. It is an agent of choice, therefore, in individuals sensitive to ester-type local anaesthetics. Lidocaine is relatively quickly absorbed. Lidocaine is metabolised in the liver by mixed-function oxidases by dealkylation to monoethyl glycine and xylidide. The latter compound retains significant local anaesthetic and toxic activity. In man about 75% of xylidide is excreted in the urine as the further metabolite 4-hydroxy-2,6-dimethylaniline. The typical dose of Dentinox gel is about 150mg containing about 0.5mg of lidocaine hydrochloride (which approximates to about 0.1 mg/kg of bodyweight). Martindale recommends that the total dose of lidocaine hydrochloride should not exceed 200mg (3mg per kg of bodyweight). Thus, the dosage of Dentinox Gel is well within this level.5.3 Preclinical safety data
Not applicable.
## Pharmaceutical Particulars
6.1 List of excipients
| | |
| --- | --- |
| Purified Water BP | 43.34 % w/w |
| Sorbitol Solution 70 % (non-crystallising) BP | 21.00 % w/w |
| Xylitol HSE | 14.00 % w/w |
| Ethanol 96% BP | 9.36 % w/w |
| Glycerol BP | 7.00 % w/w |
| Hydroxethylcellulose BP | 2.50 % w/w |
| Polyoxyl 40 hydrogenated castor oils | 1.00 % w/w |
| Pharmaceutical Liquid Flavour | 0.48 % w/w |
| Hydroxypolyethoxy Dodecane | 0.33 % w/w |
| Macrogol 300 | 0.33 % w/w |
| Sodium Saccharin | 0.10 % w/w |
| Caramel E150 | 0.07 % w/w |
| Levomenthol | 0.06 % w/w |6.2 Incompatibilities
None Known.6.3 Shelf life
3 years6.4 Special precautions for storage
Do not store above 25°C6.5 Nature and contents of container
Internally lacquered aluminium tube, the nozzle of which contains a membrane.
Pack size 10g (tube), 1 g sachet
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
