CARBAMIDE PEROXIDE: 66 Adverse Event Reports & Safety Profile

Ear Wax Removal Complete System Ear wax is an important part of your body's system for keeping dirt, bacteria and other things from causing hearing problems. When rinsing is necessary, this cleaning system helps to soften, loosen and remove the excessive ear wax. The system consists of kit with 1 bottle carbamide peroxide solution 15mL and 1 can sterile saline spray 177mL (or 125mL).

Directions for ReUsable Ear Cleaners For use in the ear only. Make sure to check physical integrity of the tool prior to use. When usingfor teh first time, begin with the COIL tool. Grasp tool comfortably between thumb, index and middle fingers. Direct toward ear. Gently advance tool toward the earcanal and SPIN tool continuously - slowly advancing into the outer portion of canal. Rotate in one direction per insertion. For additional extraction, try the BRISTLE, SCREW or CLUB tools. DO NOT POKE OR JAB INTO EAR. DO NOT FORCIBLY ADVANCE. NOT FOR DEEP CANAL INSERTION. Each person's requirements vary. Impacted earwax should be removed by a health care professional. Check with your physician. DISINFECTIONS INSTRUCTIONS: Clean with soap and warm water followed by immersing eartools in isopropyl rubbing alcohol 70%. Use tool when dry. SUGGESTED USE: Intended for EAR HYGIENE: Cleaning of debris, itch relief, exfoliation, water extraction and superficial wax around the ear and outer ear canal. Daily or less frequent use may be beneficial.

Directions Adults and Children over 12 years of age: Tilt head sideways and place 5 to 10 Earwax Removal Drops into ear Tip of applicator nozzle should NOT enter ear canal With head still sideways, insert earplugs as follows: Reach over head and pull up and back on outer ear to straighten ear canal With opposite hand, grasp earplug stem and insert by pressing forward in a circular motion, just enough to seal in drops. Do not insert deeply into canal. Repeat for other ear, if treating both ears Keep drops in ear(s) for several minutes Remove earplugs slowly with a twisting motion to gradually break the seal Use twice daily for up to four days if needed, or as directed by a doctor Any earwax remaining after the 4-day treatment may be removed by gently rinsing the ear with body-temperature water, using the Bellow Syringe Fill supplied tub 1/3 to 1/2 full with body-temperature water Fully compress Bellow Syringe and insert blue Rinse Tip into water Release the pressure on the Bellow Syringe, allowing the water to be drawn into the bellow While holding tub beneath ear, place the blue Rinse Tip into ear opening and compress bellow to rinse ear canal Children under 12 years of age : Consult a doctor

Warnings For use in the ear only Ask a doctor or pharmacist before use if you have: ear drainage or discharge recently had ear surgery dizziness pain, irritation, or rash in the ear an ear infection had an injury or perforation (hole) of the eardrum Stop use and ask doctor if : you need to use for more than four days excessive earwax remains after use of this product When using this product , avoid contact with the eyes When using earplugs , do not insert deeply into ear canal. Remove very slowly with a twisting motion to gradually break the seal. Due to the excellent seal characteristics, rapid removal may damage eardrum Keep this and all drugs out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.

Active Ingredient and Purpose . Active ingredient Purpose Carbamide peroxide 6.5%............... Earwax removal aid

Inactive Ingredients Glycerin, Oxyquinoline

Ingredients for ClearCanal® Saline Spray : USP Grade Water, USP Sodium Chloride (9mg/ml), USP Sodium Bicarbonate (0.4mg to 1.0mg/ml) to neutralize pH.

Benzalkonium

Chloride is added as a preservative