Abridged information. Please refer to Summary of Product Characteristics before using Ultracare Topical Anaesthetic Gel (benzocaine). Professional use only. For topical use only.
A smooth pink to red coloured oromucosal and gingival gel containing benzocaine 17.9% w/w as the active ingredient.
For the induction of topical anaesthesia of the oromucosa and gingiva prior to minordental procedures.
Posology and method of administration
Sufficient gel should be applied to the desired site of action to induce anaesthesia. This will normally be between 0.2 and 0.5 ml, depending on the area over which anaesthesia is required. The required amount of gel should be extracted from the bottle with a unidose syringe onto a cotton bud applicator.
Do not use on patients with known hypersensitivity or allergy to benzocaine or any of the other ingredients. Patients with methaemoglobinaemia.
Special warnings and precautions for use
Ultracare contains phenylalanine at a concentration of approximately 2.8 mg per gram.This should be taken into account in treating patients with phenylketonuria. The colour Allura Red E129 may cause allergic reactions. Caution should be exercised in the use of this product if there have been previous allergic reactions with other local anaesthetics or sunscreen products.
Interaction with other medicinal products and other forms of interaction
Benzocaine is hydrolysed to para-aminobenzoic acid which inhibits the antimicrobialactivity of sulphonamides. Concomitant use of benzocaine and sulphonamides is not recommended.
Pregnancy and lactation
Although benzocaine has been in widespread use for many years without apparent ill consequence, there is inadequate evidence of its safety in human pregnancy. Therefore, topical benzocaine should not be used in pregnancy or lactation unless considered essential by the dental practitioner.
Effects on ability to drive and use machines
Ultracare has no effect on the ability to drive or use machinery.
Hypersensitivity reactions may occur in those patients sensitive to benzocaine. Application of benzocaine on skin and mucous membranes may result in hypersensitivity reactions (burning, stinging, pruritus, erythema, rash and oedema) and contact dermatitis. Methaemoglobinaemia may occur in patients receiving high doses or repeated applications of benzocaine-containing products.
Ultracare will only be administered in the dental surgery under the direction of a dentist, and overdosage is therefore extremely unlikely. Treatment of overdose should be symptomatic and supportive. 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.
PL12139/0003 Legal category: P
Optident Ltd, International Development Centre
Valley Drive, Ilkley, West Yorkshire, LS29 8AL,
Text revised: November 2015 TOPICAL/002