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

Logo CERUMENEX EAR DROPS
SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

CERUMENEX EAR DROPS

COMPOSITION
Per 15 mL:
Triethanolamine polypeptide oleate condensate         1,57 g
Preservative:
Chlorbutol        0,5% m/m

PHARMACOLOGICAL CLASSIFICATION
A 16.2 Aural preparations, ear drops

PHARMACOLOGICAL ACTION
CERUMENEX contains a ceruminolytic agent for the softening of wax.

INDICATIONS
Routine removal of excessive impacted cerumen
Removal of cerumen; to facilitate examination of tympanum; before audiometry, to ensure accurate reading; prior to topical therapy

CONTRA-INDICATIONS
None

WARNINGS
For external use only

DOSAGE AND DIRECTIONS FOR USE
1. Hold the head to one side at an angle of 45°. Fill the ear canal with CERUMENEX ear drops and insert a cotton wool plug, soaked in the ear drops, into the ear.
2. Allow the drops to remain in the ear for not longer than 30 minutes.
3. Rinse the ear carefully with lukewarm water, using a rubber ear syringe or a cotton wool swab.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Rarely, a mild erythema of the acoustic canal, if the drops are left in for prolonged periods, or if the ear is not syringed properly.
If the drops remain in the ear for longer than 30 minutes, inflammation of the ear can occur. Syringe with caution if perforation of the ear drum is suspected.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See side-effects.

IDENTIFICATION
Clear, yellow liquid

PRESENTATION
15 mL

STORAGE INSTRUCTIONS
Store below 25°C, keep well closed and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
C/16.2/69

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NORISTAN LIMITED
326 MARKS STREET, WALTLOO, PRETORIA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
25 September 1970

ETHIMED
Divison of
NORISTAN LIMITED, WALTLOO, PRETORIA
                D 551/04

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