INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CERUMOL® EAR DROPS

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

CERUMOL® EAR DROPS

COMPOSITION:
Each 100 mL contains:
Arachis Oil         57 g
Paradichlorobenzene         2 g
Chlorbutol         5 g

PHARMACOLOGICAL CLASSIFICATION:
A 16.2 Aural medicines, ear drops.

PHARMACOLOGICAL ACTION:
Loosening of hard or soft wax plug and subsequent removal.

INDICATIONS:
Occlusion or partial occlusion of external auditory meatus by either a collection of soft wax or a harder wax plug.

CONTRA-INDICATIONS:
Otitis externa, seborrhoeic dermatitis and eczema affecting the external ear.

DOSAGE AND DIRECTIONS FOR USE:
Approximately 5 drops should be instilled into the ear with the head inclined or, better still, with the patient lying down. Should the CERUMOL tend to run out when the head is held up, a small plug of cotton wool soaked in CERUMOL, or smeared with petroleum jelly, could then be applied. Ten to thirty minutes later the softened and disimpacted cerumen can be simply removed by using a probe tipped with cotton wool or by gentle syringing.
Alternatively, the patient can himself instil the drops (as described above) two or three times a day for a few days in order to loosen the wax. In many cases this procedure is sufficient as frequently the wax will run out of its own accord making further attendance at the surgery unnecessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local irritation. Do not apply if the ear drum is perforated. Avoid contact with the eyes.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. Treatment is supportive and symptomatic.

IDENTIFICATION:
A clear oily liquid, pale amber in colour, with a characteristic odour.

PRESENTATION:
10 mL Dropper bottle.

STORAGE INSTRUCTIONS:
Store in a well stoppered container in a cool place (below 25°C).
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
H/16.2/1519

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMAFRICA (PTY) LTD
33 Hulbert Road
New Centre
Johannesburg
2001

PUBLICATION DATE OF THIS PACKAGE INSERT:
30 March 1989

Updated on this site: November 1999

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