Germolene Antiseptic Ointment

1. Name Of The Medicinal Product

Germolene Antiseptic Ointment

2. Qualitative And Quantitative Composition

Zinc Oxide Ph. Eur. 6.55%, Methyl Salicylate Ph. Eur. 3%, Phenol Ph. Eur. 1.19% and Octafonium Chloride 0.3%.

3. Pharmaceutical Form

Ointment for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For minor cuts and grazes, minor burns and scalds and blisters, sore or rough skin, wash-day hands, sunburn and the symptomatic relief of muscular pain and stiffness.

4.2 Posology And Method Of Administration

Minor cuts and grazes etc.: Clean the wound and apply directly or on a dressing.

Minor burns, scalds and blisters: Apply liberally and cover with a light bandage.

Sore, rough skin, wash-day hands, sunburn etc.: Apply directly and rub in gently.

Stiff, aching muscles: Apply liberally and massage in thoroughly.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

For external use only.

Keep out of the reach of children.

If symptoms persist, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use in pregnancy and lactation is not contraindicated. However, as with all medicines during pregnancy, caution should be exercised.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Local allergic reactions may occur. Very rarely, contact dermatitis may occur.

4.9 Overdose

It is very unlikely that overdose would occur with this pharmaceutical form. Theoretically, frequently repeated topical application on the same site could lead to skin irritation. However, since the product is only intended for minor skin trauma, extensive exposure is unlikely.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Zinc oxide is a mild astringent. Methyl salicylate is a topical analgesic and anti-inflammatory. Phenol is an antiseptic and local anaesthetic. Octafonium chloride is an antiseptic. Wool fat, yellow soft paraffin, white soft paraffin, light liquid paraffin and starch all have emollient properties.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Also contains wool fat Ph. Eur., yellow soft paraffin B. P., white soft paraffin B. P., light liquid paraffin Ph. Eur., starch Ph. Eur., menthol and colours: ponceau 4R (E124) & tartrazine (E102).

6.2 Incompatibilities

None.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Flexible aluminium tube, unlacquered internally, fitted with an integral nozzle and a polypropylene cap, containing 27g of ointment.

6.6 Special Precautions For Disposal And Other Handling

Replace closure firmly after use.

Administrative Data

7. Marketing Authorisation Holder

Bayer plc

Trading as: Bayer plc; Consumer Care Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

8. Marketing Authorisation Number(S)

PL 00010/0262

9. Date Of First Authorisation/Renewal Of The Authorisation

1^st July 2000

10. Date Of Revision Of The Text

April 2007