Bayer Limited

Germolene Ointment

The ointment contains the following active substances:

Zinc Oxide 6.55% w/w, Methyl Salicylate 3% w/w, Phenol 1.19% and Octafonium Chloride 0.3% w/w.

Excipients: Also contains wool fat (lanolin), 35.0% w/w

For a full list of excipients, see section 6.1.

Ointment

A pink smooth ointment with characteristic medicated odour.

As an antiseptic and analgesic for the topical treatment of superficial skin trauma, nappy rash, sunburn and painful muscles.

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.

Hypersensitivity to any of the ingredients.

For external use only.

If symptoms persist, consult your doctor.

Keep out of the reach of children.

Prolonged used without medical supervision could be harmful.

None known.

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

None.

Tartrazine (E102) and Ponceau 4R (E124) may cause allergic reactions.

Wool fat may cause local skin reactions (e.g. contact dermatitis).

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

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. Anhydrous lanolin, yellow soft paraffin, white soft paraffin, light liquid paraffin and starch all have emollient properties.

Not applicable.

There are no pertinent data not already described elsewhere in this SmPC.

Wool fat

Paraffin, Yellow Soft

White Soft Paraffin

Paraffin, Light Liquid

Maize Starch

Menthol, Racemic

Colours: Ponceau 4R (E124) & Tartrazine (E102).

Not applicable.

Three years.

This medicinal product does not require any special storage precautions. Replace closure firmly after use.

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

No special requirements.

Bayer Ltd,

The Atrium,

Blackthorn Rd,

Dublin 18

Ireland

PA 1410/46/1

Date of first authorisation: 01 April 1983

Date of last renewal: 01 April 2008

May 2010