Curemenex (Triethanolamine Polypeptide)

CERUMENEX®

Purdue Frederick

Triethanolamine Polypeptide

Oleate-condensate

Cerumenolytic

Indications And Clinical Uses: For removal of impacted cerumen. Cleansing prior to aural examination, treatment, or audiometry. Should not be used for routine wax removal or cleaning of the ears.

Contra-Indications: Perforated eardrum. Middle ear infection or severe inflammatory or atopic dermatitis in the external ear. Positive patch test. History of untoward reaction to Cerumenex.

Precautions: Should be used with extreme caution in patients with demonstrable dermatologic idiosyncrasies or with a history of allergic reactions in general.

In case of doubt as to the safety of use, a patch test should be performed by placing a drop of Cerumenex Drops on the flexor surface of the arm (or forearm) and covering with a small bandage strip. The test results are read and interpreted after 24 hours. A positive reaction indicates the probability of an allergic reaction following instillation in the ear.

Patients should be instructed not to exceed a 15 to 20 minute exposure of the ear canal to the medication, nor to use the drops more frequently than prescribed. If an untoward reaction occurs, the drops should be discontinued.

When administering care should be taken to avoid undue exposure of the periaural skin during the instillation and the flushing out of the medication. If the medication comes in contact with the skin, the area should be washed with soap and water. Use of proper technique will help avoid such undue exposure.

Adverse Reactions: Localized dermatitis reactions were reported in about 1% of 2 700 patients treated, ranging from a very mild erythema and pruritus of the external canal to a severe eczematoid reaction involving the external ear and periauricular tissue, generally with duration of 2 to 10 days. In all cases, complete and uneventful resolution occurred without supplemental therapy. Such therapy may consist of only symptomatic relief in mild cases and may include anti-inflammatory agents when indicated.

Dosage And Administration: Fill ear canal with Cerumenex Drops, insert cotton plug and allow to remain only 15 to 20 minutes, then gently flush ear with warm water (avoid excessive pressure).

Availability And Storage: Each mL of clear solution contains: triethanolamine polypeptide oleate-condensate 10% in propylene glycol with chlorbutanol 0.5%. Bottles of 8 and 15 mL with blunt end dropper.

CERUMENEX® Purdue Frederick Triethanolamine Polypeptide Oleate-condensate Cerumenolytic

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