Lanacane Cream

1. Name Of The Medicinal Product

Lanacane Creme

2. Qualitative And Quantitative Composition

Active Ingredient	%	Specification
Benzocaine	3.0	E.P.

3. Pharmaceutical Form

Emulsion creme in an aluminium tube.

4. Clinical Particulars

4.1 Therapeutic Indications

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.

4.2 Posology And Method Of Administration

For topical administration.

Adults and children aged twelve years and above:

Apply to the affected area. Repeat as needed three times daily.

4.3 Contraindications

Known sensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Not for use on extensive body area or on the eyes. If symptoms persist more than one week, discontinue use and consult a doctor.

For external use only.

Not suitable for children under twelve years of age.

Keep out of the reach of children.

Do not use during pregnancy without first consulting a doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Do not use in pregnancy without first consulting a doctor.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

May possibly cause sensitivity. If this occurs, treatment should be stopped and medical advice sought.

4.9 Overdose

None.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

When used as directed, some benzocaine applied topically may be absorbed, but this should be of negligible consequence. Benzocaine has the quickest onset and shortest duration of action of the commonly used topical anaesthetics.

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars

6.1 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.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Five years.

6.4 Special Precautions For Storage

Store at room temperature (below 30°C).

6.5 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

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 4AQ

8. Marketing Authorisation Number(S)

PL 00063/0671

9. Date Of First Authorisation/Renewal Of The Authorisation

26^th April 1990 / 23^rd July 1996

10. Date Of Revision Of The Text

26/07/2011