Indications and uses
Use occasionally as an aid to soften, loosen , and remove excessive earwax.
Use occasionally as an aid to soften, loosen , and remove excessive earwax.
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 ...
Carbamide Peroxide 6.5%
Earwax Removal Aid
Use occasionally as an aid to soften, loosen , and remove excessive earwax.
Do not use:
Glycerin, Oxyquinoline
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.
Keep out of reach of Children
Do not use:
If you have had an allergic reactionto carbamide peroxide or other ingredients in teh dropper bottle.
If you have ear drainage or discharge, ear pain, ear infections, irritation, rash in the ear, or are dizzy. (Please consult a doctor with concerns).
If you have an injury or perforation (hole) of the eardrum or after ear surgery or mastoid surgery, unless directed by a doctor.
More than a twice a week.
For children under 12 years of age.
If you have tubes in your ears.
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13709-313-01 | Wax Out Plus | 1 in 1 KIT | SOLUTION/ DROPS | 1 | 2 | |
| 13709-313-01 | Wax Out Plus | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 13709-313 | 13709-313-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OXYQUINOLINE | 5UTX5635HP | IACT |
| CARBAMIDE PEROXIDE | 31PZ2VAU81 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
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 |
|---|---|---|---|---|---|---|
| Wax Out Plus | CARBAMIDE PEROXIDE DROPS | NEILMED PHARMACEUTICALS INC | cf64f4b8-279c-8c1d-e053-2995a90ac853 | 2024-01-11 | Warnings | 13709-313-01 13709-313 13709031301 0eb0da5e-0fa4-b442-e063-6394a90a08f4 cf64f4b8-279c-8c1d-e053-2995a90ac853 |
Adverse event summaries are temporarily unavailable. Other product information remains available.