Wax Out Plus

Manufacturer
NEILMED PHARMACEUTICALS INC
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:05

Label at a glance#

ProductWax Out Plus
Active ingredientCARBAMIDE PEROXIDE
Label structure12 sections

Indications and uses

Use occasionally as an aid to soften, loosen , and remove excessive earwax.

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Drug Facts Carbamide Peroxide drops Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Earwax Removal Aid

Uses

INTENDED USE OF THE DEVICE

Use occasionally as an aid to soften, loosen , and remove excessive earwax.

Warnings

OTC - DO NOT USE SECTION

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.

When using this product:

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • Keep out of reach of children
  • If swallowed, get medical help or contact a poison control center immediately.
  • If accidental contact with eyes occurs, flush eyes with water and consult a doctor.
  • System is designed for a single user to reduce the risk of contamination. DO NOT SHARE WITH OTHERS
  • Individuals with Meniere's Syndrome or those experiencing dizziness, vertigo, impacted earwax or other ear problems should not use this product unless directed by a physician.
  • Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

Other Information

OTHER SAFETY INFORMATION

  • Keep cap on plastic bottle when not in use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Oxyquinoline

Directions for ReUsable Ear Cleaners

INDICATIONS & USAGE SECTION

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 for Dosing

DOSAGE & ADMINISTRATION SECTION

  • To aid with the softening of teh earwax, you may use NeilMed Clear Canal Earwax Softener in conjunction with the eartools to provide maiximum benefit.
  • Remove the cap from the NeilMed Clear Canal EarWax Softener bottle and squuze a few drops of the solution into the cavity of the cap. Dip the tip of the ear tool into the solution so that the tip of the tool is coated with softener solution. Follow the directions given for use of the tools.
  • Wash the cap with warm water and dry completely before placing back on softener bottle
  • If you wish, you may also place 10 drops of NeilMed Claer Canal Earwax Softener in teh earcanals as directed prior to use of the eartools. Keep ear plugged for 5-10 minutes. Now use the tools to remove the softened earwax.

when Using this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children

Warnings :

WARNINGS SECTION

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.

WaxOut PLus - Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Waxout PlusWaxout Plus

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN2
702050carbamide peroxide 65 MG/ML Otic SolutionSCD2
702050carbamide peroxide 6.5 % Otic SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-313-01Wax Out Plus1 in 1 KITSOLUTION/ DROPS12
13709-313-01Wax Out Plus15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-313WAX OUT PLUS (CARBAMIDE PEROXIDE DROPS) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 2 package rows20240112_cf64f4b8-279c-8c1d-e053-2995a90ac853.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-31313709-313-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYQUINOLINE5UTX5635HPIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wax Out PlusCARBAMIDE PEROXIDE DROPSNEILMED PHARMACEUTICALS INCcf64f4b8-279c-8c1d-e053-2995a90ac8532024-01-11WarningsExact identifier
ndc (package): 13709-313-01
ndc (product): 13709-313
ndc11 (package): 13709031301
spl id: 0eb0da5e-0fa4-b442-e063-6394a90a08f4
spl set id: cf64f4b8-279c-8c1d-e053-2995a90ac853

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.