NeilMed Clear Canal Earwax Removal kit

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#

ProductNeilMed Clear Canal Earwax Removal kit
Active ingredientCARBAMIDE PEROXIDE
Label structure15 sections

Indications and uses

For occasional use as an aid to soften, loosen, and remove excessive earwax.

Dosage and administration

Adults and children over 12 years of age: Tilt head sideways Place 10 drops into each ear Tip of the applicator should not enter ear canal Keep drops in the ears for ten minutes by keeping your head tilted or using earplugs Rinse ears after treatment by gently flusing each ear with NeilMed®ClearCanal® spray or bulb syringe Use up to twice per week, or as recommended by your physician.

Storage and handling

Store product in the outer carton, and do not discard carton or enclosed printed materials. Product will foam on contact with earwax due to release of oxygen; there may be an associated crackling sound. Keep cap on bottle when not in use. Contents in canister are under pressure; do not puncture or incinerate Recommended storage conditions: Store between 59°F and 86°F (15°C to 30°C). Product can temporarily be expo...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Carbamide Peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Earwax Softener

Uses

INDICATIONS & USAGE SECTION

For occasional use as an aid to soften, loosen, and remove excessive earwax.

! Warnings

WARNINGS SECTION

Avoid using the product and ask a doctor before use if you have :

  • Ear pain, drainage or discharge
  • Impacted earwax
  • Ear infection, irritation or rash in the ear.
  • Meniere's Syndrome, dizziness, or vertigo
  • An injury or perforation (hole) of the eardrum
  • Tubes in the ears
  • Has recent ear/mastoid surgery
  • Had an allergic reaction to carbamide peroxide or other ingredients in this product in the past.
  • Heart disease, high blood pressure, thyroid disease or diabetes

To prevent contamination, do not share this product with others.

When using this product:

OTC - WHEN USING SECTION

Avoid contact with the eyes. If accidental contact occurs, flush eyes with water and consult a doctor.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Excessive earwax remains after use of this product
  • You wish to use this product more than twice per week

Keep this and all drugs out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children under 12 years should not use this product.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions FOR USE IN THE EAR ONLY

INDICATIONS & USAGE SECTION

Adults and children over 12 years of age:

  • Tilt head sideways
  • Place 10 drops into each ear
  • Tip of the applicator should not enter ear canal
  • Keep drops in the ears for ten minutes by keeping your head tilted or using earplugs
  • Rinse ears after treatment by gently flusing each ear with NeilMed®ClearCanal® spray or bulb syringe
  • Use up to twice per week, or as recommended by your physician.

Other Information:

STORAGE AND HANDLING SECTION

  • Store product in the outer carton, and do not discard carton or enclosed printed materials.
  • Product will foam on contact with earwax due to release of oxygen; there may be an associated crackling sound.
  • Keep cap on bottle when not in use.
  • Contents in canister are under pressure; do not puncture or incinerate

Recommended storage conditions:

  • Store between 59°F and 86°F (15°C to 30°C). Product can temporarily be exposed to temperatures ranging from 41ºF to 131ºF (5ºC to 55ºC) during transportation.
  • Store out of sunlight, away from heat sources and avoid freezing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Oxyquinoline

Ingredients for ClearCanal® Saline Spray :

INACTIVE INGREDIENT SECTION

  • 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

Contents :

ACCESSORIES

1 can saline spray 75ml (2.53 fl oz), 1 bottle of ear drops 15ml (0.5 fl oz), 1 drainage collection cup, 2 ear plugs, 1 waxout tool and 1 soft silicone ear syringe. Colors of parts may vary.

Directions:

DOSAGE & ADMINISTRATION SECTION

This product is intended for use on adults and children over 12 years of age. Consult your physician for use on children under 12.

Tilt head sideways and place 10 drops of ClearCanal Carbamide peroxide into each ear canal by squeezing the plastic dropper bottle provided with this system. The tip of bottle should not enter ear canal.

Keep drops in ear for 10 minutes by head tilted or placing enclosed ear plugs in ears. It is normal to feel warmth in ear due to carbamide peroxide. Remove ear plugs. Attach the special drainage collection cup to the canister to avoid the rinse solution dripping out of your ear. Flush ears with the NeilMed ClearCanal specially designed actuator nozzle for 10 seconds or as desired to achieve adequate flushing. Gently tilt head side to side to drain out residual liquid and dry ears with a clean dry towel wrapped on a finger.

ClearCanal Earwax Removal Complete Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NeilMed ClearCanal Earwax Removal KitNeilMed ClearCanal Earwax Removal Kit

ClearCanal Earwax Removal Saline Spray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clearcanal earwax Removal saline sprayClearcanal earwax Removal saline spray

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
13709-314-01NeilMed Clear Canal Earwax Removal kit1 in 1 KITSOLUTION/ DROPS12
13709-314-01NeilMed Clear Canal Earwax Removal kit15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-314NEILMED CLEAR CANAL EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 2 package rows20240112_d330552d-07b6-f01e-e053-2a95a90a7ca5.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-31413709-314-01

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
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
GLYCERINPDC6A3C0OXIACT
OXYQUINOLINE5UTX5635HPIACT

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
NeilMed Clear Canal Earwax Removal kitCARBAMIDE PEROXIDENEILMED PHARMACEUTICALS INCd330552d-07b6-f01e-e053-2a95a90a7ca52024-01-11WarningsExact identifier
ndc (package): 13709-314-01
ndc (product): 13709-314
ndc11 (package): 13709031401
spl id: 0eb0d3b3-1a54-1c93-e063-6294a90a6d13
spl set id: d330552d-07b6-f01e-e053-2a95a90a7ca5

Reported adverse events (FAERS/openFDA)#

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