- Approval Id
- a95a0738fff4a3f5
- Drug Approval Emc Name
- Orajel Extra Strength
- Drug Name
- Orajel Extra Strength
- Company Name
- Church & Dwight UK Ltd
- Company Address
- Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ
- Company Website
- //www.churchdwight.com/
- Company Telephone
- +44 (0)1303 299 592 (sales enquires only)
- Company Medical Info Direct Line
- +44 0800 028 1454
- Company Medical Info Email
- ChurchDwightMC@eversana.com
- Company Customer Care Direct Line
- +44 0800 028 1454
- Atc Code
- N01BA05
- Legal Category
- Pharmacy
- Authorisation Holder
- Church & Dwight UK LimitedPremier House, Shearway Business ParkPent Road,Folkestone, Kent,CT19 4RJUnited Kingdom
- Authorisation Number
- PL 00203/0228
- Authorisation Date
- 21 September 2000
- Instruction Authorisation Holder
- Church & Dwight UK LimitedPremier House, Shearway Business ParkPent Road,Folkestone, Kent,CT19 4RJUnited Kingdom
- Instruction Authorisation Number
- PL 00203/0228
- Instruction Authorisation Date
- 21 September 2000
- Instruction Composition
- Benzocaine 20% w/w.For full list of excipients, see Section 6.1.
- Instruction Dosage Form
- Dental gel
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For temporary rapid relief of toothache pain associated with presence of open carious lesions and direct exposure of a vital dental pulp.4.2 Posology and method of administration
\*\*Adults and children aged 12 years and over.\*\*
Directions:• Remove cap• Cut off tip of tube on score mark.• With a clean finger or swab apply an amount of gel the size of a green pea into the tooth cavity.• Use up to 4 times daily.• Do not use continuously. If toothache persists, consult your dentist.Not for use in children below the age of 12 years.4.3 Contraindications
Known sensitivity to benzocaine or any of the other ingredients.Not to be used in those individuals suspected of lacking the normal ability to convert methaemoglobin to haemoglobin, see section 4.4 Special warnings and precautions for use and section 4.8 Undesirable effects.Not for use in children below the age of 12 years.4.4 Special warnings and precautions for use
Orajel® Extra Strength is intended for short-term use until a dentist can be consulted. Do not use continuously.Do not exceed recommended dose.The product contains sorbic acid which may cause local skin reactions, e.g. contact dermatitis.Avoid drinking hot liquids whilst using Orajel® Extra Strength.Do not use if there is a family history of methaemoglobinaemia.4.5 Interaction with other medicinal products and other forms of interaction
Benzocaine, like other derivatives of para-aminobenzoic acid, inhibits the actions of sulphonamides and therefore should not be used concomitantly with any sulphonamide.4.6 Pregnancy and lactation
There is inadequate evidence of safety of benzocaine in human pregnancy, but it has been in wide use for many years without apparent ill consequences. No clinical data are available on the use of this product during pregnancy and lactation.4.7 Effects on ability to drive and use machines
No effect on subjects' ability to drive or operate machines.4.8 Undesirable effects
Application of benzocaine on skin and mucous membranes has resulted in hypersensitivity reactions (burning, stinging, pruritis, erythema, rash and oedema), contact dermatitis and methaemoglobinaemia in a few cases in infants, children and adults.If symptoms persist, or are severe, or are accompanied by fever, headache, breathlessness, nausea and vomiting, consult a doctor.
\*\*\*\*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 at: www.mhra.gov.uk/yellowcard.4.9 Overdose
Excessive absorption of benzocaine may produce methaemoglobinaemia in infants, children, and adults. The first clinical signs are cyanotic (greyish) skin discolouration (most notably on mucous membranes) and signs of unusual breathing or breathlessness.Methaemoglobinaemia may be treated by the intravenous administration of 1% methylene blue. Treatment of overdose should be symptomatic and supportive.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Local anaesthetics, ATC code: N01BA05Benzocaine is a local anaesthetic of the ester type with rapid onset, acting to produce reversible loss of sensation by preventing or diminishing the generation and transmission of sensory nerve impulses near the site of application. Depolarisation of the neuronal membrane and ion exchange are reversibly inhibited.5.2 Pharmacokinetic properties
Benzocaine is absorbed through mucous membranes and damaged skin.Anaesthetics of the ester type are hydrolysed by esterases in the plasma and, to a lesser extent, in the liver.5.3 Preclinical safety data
There are no additional pre-clinical data of relevance to the prescriber.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Macrogol 400Polyethylene Glycol 3350SSodium SaccharinSorbic AcidNatural Spearmint FlavourClove OilCitric acid6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years6.4 Special precautions for storage
No special precautions for storage.6.5 Nature and contents of container
Low density polyethylene tube with external acrylate coating, medium density polypropylene cap. Tubes contain 5.3 g gel.6.6 Special precautions for disposal and other handling
Not applicable
- Instruction Content
- ## Composition
Benzocaine 20% w/w.For full list of excipients, see Section 6.1.
## Pharmaceutical Form
Dental gel
## Clinical Particulars
4.1 Therapeutic indications
For temporary rapid relief of toothache pain associated with presence of open carious lesions and direct exposure of a vital dental pulp.4.2 Posology and method of administration
\*\*Adults and children aged 12 years and over.\*\*
Directions:• Remove cap• Cut off tip of tube on score mark.• With a clean finger or swab apply an amount of gel the size of a green pea into the tooth cavity.• Use up to 4 times daily.• Do not use continuously. If toothache persists, consult your dentist.Not for use in children below the age of 12 years.4.3 Contraindications
Known sensitivity to benzocaine or any of the other ingredients.Not to be used in those individuals suspected of lacking the normal ability to convert methaemoglobin to haemoglobin, see section 4.4 Special warnings and precautions for use and section 4.8 Undesirable effects.Not for use in children below the age of 12 years.4.4 Special warnings and precautions for use
Orajel® Extra Strength is intended for short-term use until a dentist can be consulted. Do not use continuously.Do not exceed recommended dose.The product contains sorbic acid which may cause local skin reactions, e.g. contact dermatitis.Avoid drinking hot liquids whilst using Orajel® Extra Strength.Do not use if there is a family history of methaemoglobinaemia.4.5 Interaction with other medicinal products and other forms of interaction
Benzocaine, like other derivatives of para-aminobenzoic acid, inhibits the actions of sulphonamides and therefore should not be used concomitantly with any sulphonamide.4.6 Pregnancy and lactation
There is inadequate evidence of safety of benzocaine in human pregnancy, but it has been in wide use for many years without apparent ill consequences. No clinical data are available on the use of this product during pregnancy and lactation.4.7 Effects on ability to drive and use machines
No effect on subjects' ability to drive or operate machines.4.8 Undesirable effects
Application of benzocaine on skin and mucous membranes has resulted in hypersensitivity reactions (burning, stinging, pruritis, erythema, rash and oedema), contact dermatitis and methaemoglobinaemia in a few cases in infants, children and adults.If symptoms persist, or are severe, or are accompanied by fever, headache, breathlessness, nausea and vomiting, consult a doctor.
\*\*\*\*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 at: www.mhra.gov.uk/yellowcard.4.9 Overdose
Excessive absorption of benzocaine may produce methaemoglobinaemia in infants, children, and adults. The first clinical signs are cyanotic (greyish) skin discolouration (most notably on mucous membranes) and signs of unusual breathing or breathlessness.Methaemoglobinaemia may be treated by the intravenous administration of 1% methylene blue. Treatment of overdose should be symptomatic and supportive.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Local anaesthetics, ATC code: N01BA05Benzocaine is a local anaesthetic of the ester type with rapid onset, acting to produce reversible loss of sensation by preventing or diminishing the generation and transmission of sensory nerve impulses near the site of application. Depolarisation of the neuronal membrane and ion exchange are reversibly inhibited.5.2 Pharmacokinetic properties
Benzocaine is absorbed through mucous membranes and damaged skin.Anaesthetics of the ester type are hydrolysed by esterases in the plasma and, to a lesser extent, in the liver.5.3 Preclinical safety data
There are no additional pre-clinical data of relevance to the prescriber.
## Pharmaceutical Particulars
6.1 List of excipients
Macrogol 400Polyethylene Glycol 3350SSodium SaccharinSorbic AcidNatural Spearmint FlavourClove OilCitric acid6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years6.4 Special precautions for storage
No special precautions for storage.6.5 Nature and contents of container
Low density polyethylene tube with external acrylate coating, medium density polypropylene cap. Tubes contain 5.3 g gel.6.6 Special precautions for disposal and other handling
Not applicable
