Baby Orajel Nighttime Formula (Topical application)

For symptomatic relief of minor pain, itching, and irritation in the following localised skin conditions, such as insect bites, nettle stings, minor skin abrasions, and external genital and external anal itching.

For short term use only. If pain persists for more than 7 days, or worsens, seek medical advice.

Posology

For adults, the elderly and children aged12 years and over:

Apply a small amount to the affected area up to 3 times a day.

Method of administration

For topical administration.

(PABA), parabens or paraphenylenediamine or to commercial hair dyes as there is cross-sensitivity between these products.

A history of allergy to local anaesthetics such as procaine, butacaine or any other 'caine' anaesthetics.

In patients who have a history of or are suspected to have methaemoglobinaemia.

Do not use with sulphonamides.

Do not use with cholinesterase inhibitors.

Do not apply to large areas of skin, eczematous, sunburnt, infected or broken skin.

Local anaesthetics should not be used in patients with complete heart block.

Not for use on extensive body area or on the mouth or eyes or under conditions in which significant inhalation is likely.

None.

Adverse events which have been associated with benzocaine are given below, listed by system organ class and frequency. Frequencies are defined as: very common (> 1/10), common (>1/100 and <1/10), uncommon (> 1/1000 and <1/100), rare (> 1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

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

Symptoms

There have been no reports of over dosage with the use of benzocaine with this dosage form.

Management

In the unlikely case of over dosage, treatment should be symptomatic and supportive.

Pharmacotherapeutic group: Antipruritics, incl. Antihistamines, Anesthetics, etc;

ATC Code: D04 AB04

Benzocaine applied to the skin acts as a topical local anaesthetic, acting on nerve endings and receptors, temporarily reducing the itching and minor pain associated with various thermal, mechanical or chemical stimuli. The vanishing creme base also helps soothe, lubricate, and protect irritated skin.

When used as directed, some benzocaine applied topically may be absorbed through the skin and mucous membranes and is hydrolysed by esterases in the plasma and in the liver, but this should be of negligible consequence. Benzocaine has the quickest onset and shortest duration of action of the commonly used topical anaesthetics.

None

None known.

None