Indications and uses
for occasional use as an aid to soften, loosen, and remove excessive earwax
for occasional use as an aid to soften, loosen, and remove excessive earwax
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...
Carbamide peroxide 6.5%
Earwax removal aid
for occasional use as an aid to soften, loosen, and remove excessive earwax
For use in the ear only
Ask a doctor or pharmacist before use if you have:
Stop use and ask doctor if:
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.
Adults and Children over 12 years of age:
Tip of applicator nozzle should NOT enter ear canal
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.
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
Call (586) 427-7560 during business hours (EST)
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66354-007-82 | ProRinse Earwax Removal System | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | 1 | |
| 66354-007-82 | ProRinse Earwax Removal System | 1 in 1 BOX | SOLUTION/ DROPS | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 66354-007 | 66354-007-82 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| WATER | 059QF0KO0R | IACT |
| CARBAMIDE PEROXIDE | 31PZ2VAU81 | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ProRinse Earwax Removal System | CARBAMIDE PEROXIDE | McKeon Products Inc | ca82db28-1ef7-41c6-a46b-7bfc7b09281c | 2026-02-09 | Warnings | 66354-007-82 66354-007 66354000782 4a636cb5-104c-7811-e063-6294a90afcb0 ca82db28-1ef7-41c6-a46b-7bfc7b09281c |
Adverse event summaries are temporarily unavailable. Other product information remains available.