ORAJEL Dental gel (2015)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Orajel Mouth Gel.
Qualitative and quantitative composition
Benzocaine 10% w/w. For full list of excipients, see Section 6.1.
Pharmaceutical form
Dental gel.
Therapeutic indications
For temporary relief from the pain and tenderness associated with mouth ulcers and from wearing dentures.
Posology and method of administration
Adults and children over 12 years. Directions: Clean and dry the affected area. Cut off tip of tube on score mark. Apply a thin layer of Orajel Mouth Gel to the areas inside the mouth which are tender ...
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 ...
Special warnings and precautions for use
Orajel Mouth Gel is intended for short-term use until a dentist or doctor can be consulted. Treatment with benzocaine products such as Orajel Mouth Gel may mask symptoms associated with more serious conditions ...
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.
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 ...
Effects on ability to drive and use machines
No effect on subjects' ability to drive or operate machines.
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 ...
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) ...
Pharmacodynamic properties
Pharmacotherapeutic group: Local anaesthetics ATC code: N01BA05 Benzocaine is a local anaesthetic of the ester type, acting to produce reversible loss of sensation by preventing or diminishing the generation ...
Pharmacokinetic properties
Benzocaine is rapidly 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.
Preclinical safety data
There are no additional pre-clinical data of relevance to the prescriber.
List of excipients
Chlorothymol Eugenol FD&C Red No. 40 (Allura Red AC): E129 Passion fruit flavour Macrogol 400 Polyethylene glycol 3350 Propylene glycol: E1520 Purified water Sodium saccharin: E954 Sorbic acid: E200
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
No special precautions for storage.
Nature and contents of container
Low density polyethylene tube with external acrylate coating, medium density polypropylene cap. Tubes contain 5.3 g.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Church & Dwight UK Limited, Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom
Marketing authorization number(s)
PL 00203/0229
Date of first authorization / renewal of the authorization
21 September 2000
Date of revision of the text
08 April 2015
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