DOSAGE & ADMINISTRATION SECTION.

Directions. FOR USE IN THE EAR ONLY.Adults and children over 12 years of age:tilt head sidewaysplace to 10 drops into ear canal. 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 days if needed, or as directed by doctor.any wax remaining after treatment may be removed by gently flushing the ear with warm water, using soft rubber bulb ear syringe.Children under 12 years of age: consult doctor. Adults and children over 12 years of age:. tilt head sideways. place to 10 drops into ear canal. 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 days if needed, or as directed by doctor.. any wax remaining after treatment may be removed by gently flushing the ear with warm water, using soft rubber bulb ear syringe.

INACTIVE INGREDIENT SECTION.

Inactive ingredients. adipic acid, anhydrous glycerin, polysorbate 80.

INDICATIONS & USAGE SECTION.

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

OTC - ACTIVE INGREDIENT SECTION.

Active ingredient. Carbamide peroxide 6.5%.

OTC - ASK DOCTOR SECTION.

Ask doctor before use if you have ear drainage or dischargeear painirritation or rash in the eardizzinessan injury or perforation (hole) of the eardrumrecently had ear surgery. if you have ear drainage or discharge. ear pain. irritation or rash in the ear. dizziness. an injury or perforation (hole) of the eardrum. recently had ear surgery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

OTC - PURPOSE SECTION.

Purpose. Earwax removal aid.

OTC - QUESTIONS SECTION.

Questions 1-866-467-2748.

OTC - STOP USE SECTION.

Stop use and ask doctor if you need to use for more than four daysexcessive ear wax remains after use this product. you need to use for more than four days. excessive ear wax remains after use this product.

OTC - WHEN USING SECTION.

When using this product avoid contact with the eyes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. Compare to the active ingredient in Debrox(R) DropsNDC 21130-793-15Ear Wax Removal Aid DropsCarbamide Peroxide 6.5%Ear Wax Removal Aid oSafe GentleoMicrofoam Cleansing ActionoEasy to use InstructionsNET WT 0.5 FL OZ (15 mL)TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORNDISTRIBUTED BY BETTER LIVING BRANDS LLCP.O. BOX 99, PLEASANTON, CA 94566-00091-888-723-3929www.betterlivingbrandsLLC.comIMPORTANT: Keep this carton for future labeling.This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox(R) Drops.. oSafe Gentle. oMicrofoam Cleansing Action. oEasy to use Instructions. Ear Wax Removal Aid Drops.

SPL UNCLASSIFIED SECTION.

Drug Facts.

WARNINGS SECTION.

Warnings. Ask doctor before use if you have ear drainage or dischargeear painirritation or rash in the eardizzinessan injury or perforation (hole) of the eardrumrecently had ear surgery. if you have ear drainage or discharge. ear pain. irritation or rash in the ear. dizziness. an injury or perforation (hole) of the eardrum. recently had ear surgery. When using this product avoid contact with the eyes. Stop use and ask doctor if you need to use for more than four daysexcessive ear wax remains after use this product. you need to use for more than four days. excessive ear wax remains after use this product. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.