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ORAJEL EXTRA STRENGTH

Active substance(s): BENZOCAINE / BENZOCAINE / BENZOCAINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Orajel Extra Strength

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzocaine 20% w/w
For full list of excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Dental gel

4

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 you have 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
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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Local anaesthetics, ATC code: N01BA05
Benzocaine 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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Macrogol 400
Polyethylene Glycol 3350S
Sodium Saccharin
Sorbic Acid
Natural Spearmint Flavour
Clove Oil
Citric acid

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years.

6.4

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
Not applicable.

7.

MARKETING AUTHORISATION HOLDER
Church & Dwight UK Limited
Premier House, Shearway Business Park
Pent Road,
Folkestone, Kent,
CT19 4RJ
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00203/0228

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
21 September 2000

10

DATE OF REVISION OF THE TEXT
07/05/2015

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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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