Active ingredient                                    Purpose



Carbamide Peroxide 6.5%..........................Earwax Removal Aid

Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.

Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.

Warnings



Ask a doctor before use if you have

- ear drainage or discharge - ear pain

- irritation or rash in the ear - dizziness

- an injury or perforation (hole) of the ear drum

- recently had ear surgery



Stop use and ask a doctor if

- you need to use for more than four days

- excessive wax remains after use of this product



When using this product - avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult your doctor.



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

FOR USE IN THE EAR ONLY

Unscrew cap from bottle. Remove foil safety seal from bottle. Affix applicator cap to bottle.



Adults and children over 12 years of age:

- tilt head sideways and place 5 to 10 drops into ear

- tip of applicator should not enter ear canal

- keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear

- use twice daily for up to 4 days if needed, or as directed by a doctor

- any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber ear syringe.

- when the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal



Children under 12 years of age: consult a doctor.



Other information

- avoid exposing the bottle to excessive heat and direct sunlight

- keep cap on bottle when not in use

- lot no. & exp date: see label, bottom of container or box

- retain carton for future reference on full labeling

- Note: Drops foam on contact with ear wax due to release of oxygen. There may be an associated "cracking" sound

- Note: Oversize packaging for ease in reading label information. Contains one bottle.

- Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

Inactive ingredients



anhydrous glycerin, citric acid, propylene glycol, sodium lauryl sulfate, sodium citrate, tartaric acid

 Adverse Drug Event Call toll free: (800) 616-2471

NDC 63187-187-15

EAR WAX REMOVER

WITH IRRIGATOR

Earwax Removal Aid

(carbamide peroxide 6.5%)

Distributed by:

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150  USA

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320