Active substance(s): BENZOCAINE / BENZOCAINE / BENZOCAINE
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Emulsion creme in an aluminium tube.
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.
Posology and method of administration
For short term use only. If pain persists for more than 7 days, or worsens, seek
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.
Hypersensitivity to benzocaine or to any of the excipients listed in section 6.1
or paraaminobenzoic acid (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 (see section 4.8).
Do not use with sulphonamides (see section 4.5).
Do not use with cholinesterase inhibitors (see section 4.5).
Do not apply to large areas of skin, eczematous, sunburnt, infected or broken
Special warnings and precautions for use
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.
Interaction with other medicinal products and other forms of interaction
Sulphonamides: Benzocaine is metabolised to para-aminobenzoic acid and
may antagonise the effects of sulphonamides.
Cholinesterase Inhibitors: Cholinesterase inhibitors inhibit the metabolism
Fertility, pregnancy and lactation
Do not use in pregnancy or during breast feeding without first consulting a
There are limited amounts of data from the use of benzocaine in pregnant
There is insufficient information on the excretion of benzocaine metabolites in
No known effects
Effects on ability to drive and use machines
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.
System Organ Class
Blood and Lymphatic Not known
Hypersensitivity reactions, dermatitis
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:
There have been no reports of over dosage with the use of benzocaine with
this dosage form.
In the unlikely case of over dosage, treatment should be symptomatic and
Pharmacotherapeutic group: Antipruritics, incl. Antihistamines,
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.
Preclinical safety data
List of excipients
Chlorothymol, diethylene glycol monoethyl ether, docusate sodium, fragrance,
glycerine, glycerol monostearate, isopropyl alcohol, stearic acid, sulfonated castor oil,
triethanolamine, water, zinc oxide.
Special precautions for storage
Store at room temperature (below 30°C).
Nature and contents of container
In 30 gram and 60 gram aluminium tubes with a membrane covered nozzle and white high
density polyethylene cap, overpacked in a printed folding cardboard unit carton
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
26th April 1990 / 23rd July 1996
DATE OF REVISION OF THE TEXT
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.