Audax Ear Drops Solution Choline Salicylate 20%w/v Glycerol 12.6%w/v

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glycerol; Choline salicylate

Available from:

GR Lane Health Products Ltd

ATC code:

S02DA

INN (International Name):

Glycerol; Choline salicylate

Dosage:

20 %w/v +12.6 percent weight/volume

Pharmaceutical form:

Ear drops, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Analgesics and anesthetics

Authorization status:

Not marketed

Authorization date:

1983-04-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Audax Ear Drops Solution
Choline Salicylate 20%w/v
Glycerol 12.6%w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Choline Salicylate 20.0%w/v.
Glycerol 12.6%w/v.
Excipients: also contains 1.25%w/v ethylene oxide polyoxypropylene
glycol and up to 66.6%w/v propylene glycol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ear drops solution
Clear, faintly tan solution, with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For relief of pain in otitis externa and media, furuncles and other
local inflammation, softening of earwax and aid to
earwax removal.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical into ear.
Place the head on one side with the affected ear uppermost. Completely
fill the external auditory canal with drops. The
ear should be plugged with cotton wool soaked with the eardrops or a
wick may be inserted if preferred. Audax Ear
Drops should be instilled every 3 to 4 hours until permanent relief of
symptoms is obtained.
4.3 CONTRAINDICATIONS
1.
Use in patients hypersensitive to salicylates.
2.
Perforated ear drum.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
If symptoms persist, the doctor should be consulted.
2.
If the patient is under the doctor’s care or is on any medication,
the doctor should be consulted before using.
3.
Contains propylene glycol and esters which may cause skin irritation.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None stated.
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