EARCALM Spray Ref.[6057] Active ingredients: Acetic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom

Therapeutic indications

EarCalm Spray is indicated for the treatment of superficial infections of the external auditory canal.

Posology and method of administration

Route of administration

Topical. For external aural use to the external auditory canal only.

Adults, children, aged 12 years and above, and the elderly

For treatment of superficial infections of the outer ear: one metered dose (60 milligrams) to be administered directly into each affected ear at least three times daily (morning, evening and after swimming, showering or bathing). Maximum dosage frequency one spray every 2-3 hours.

Treatment should be continued until two days after symptoms have disappeared but no longer than 7 days.

Before using the product for the first time, prime the pump by depressing actuator 6-10 times until a fine spray is obtained. Use within 1 month of first actuation. If more than one week has elapsed since the last use, dispose of the contents of the pump chamber by 1 or 2 depressions of the actuator.

Overdose

Overdosage by this route is extremely unlikely.

If EarCalm should be accidentally swallowed, neutralisation with milk or water may be required.

Shelf life

Shelf life of the product as packaged for sale: 24 months from the date of manufacture.

Shelf life after first opening of the container: Use within one month of first use.

Special precautions for storage

Do not store above 25°C. Keep container upright in the outer carton.

Nature and contents of container

5 ml of the product is supplied in a 8.5ml capacity amber glass bottle fitted with a spray device.

Special precautions for disposal and other handling

Shake the bottle well before use. Before first use, press actuator down several times to obtain a fine spray. Each press then delivers one metered dose. Do not inhale the spray. Administer spray directly by gently placing nozzle tip into ear opening and pressing down once on the actuator.

Use within one month of first use. If there is a period of more than one week since last use, press actuator down a few times before using again.

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