FDA.reportPublic FDA data

DEBROX

Manufacturer
A-S Medication Solutions
Effective date
2025-09-03
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:39:11

Label at a glance#

ProductDEBROX
Active ingredientCARBAMIDE PEROXIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

FOR   USE   IN   THE   EAR   ONLY adults   and   children   over   12   years   of   age: tilt head sideways place 5 to 10 drops into ear tip of applicator should not enter ear canal keep drops in ear for several minutes by keeping head tilted or placing cotton in ear • use twice daily for up to four days if needed, or as directed by a doctor any wax remaining after treatment may be removed by gently flushing the ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Debrox Earwax Removal Aid

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5% non USP

Purpose

OTC - PURPOSE SECTION

Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

you need to use for more than four days

excessive earwax remains after use of this product

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

FOR USE IN THE EAR ONLY

adults and children over 12 years of age:

tilt head sideways place 5 to 10 drops into ear tip of applicator should not enter ear canal keep drops in ear for several minutes by keeping head tilted or placing cotton in ear • use twice daily for up to four days if needed, or as directed by a doctor any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe

children under 12 years: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • do not store above 25C (77F)
  • store bottle in the outer carton, in an upright position
  • product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound.
  • keep tip on bottle when not in use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water

Questions?

OTC - QUESTIONS SECTION

1-866-255-5202  Debrox.com

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4201

NDC: 50090-4201-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

Carbamide Peroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN13
827654Debrox 6.5 % Otic SolutionPSN13
827654carbamide peroxide 65 MG/ML Otic Solution [Debrox]SBD13
702050carbamide peroxide 65 MG/ML Otic SolutionSCD13
702050carbamide peroxide 6.5 % Otic SolutionSY13
827654Debrox 6.5 % Otic SolutionSY13
827654Debrox 65 MG/ML Otic SolutionSY13

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00350090420104(17)991231(10)9987654(21)AA000000GTIN-14: 00350090420104
GTIN-12: 350090420104
UPC-A: 350090420104
EAN-13: 0350090420104
GTIN storage (14 digits): 00350090420104		lbl500904201.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4201-0DEBROX15 mL in 1 BOTTLE, DROPPERLIQUID1513
50090-4201-0DEBROX1 in 1 CARTONLIQUID113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4201-0ML - Milliliter50090-4201f5f268aa-6a66-4d3b-abf8-0a77c033102e12024-08-12

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-420150090-4201-0
63029-321

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
CITRIC ACID2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
AQUA059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102023-12-05full-release2026-06-01 00:03:19

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEBROXCARBAMIDE PEROXIDEA-S Medication Solutions8d6f1769-eb44-4bde-b3fa-3ff4658b7dd12025-09-03WarningsExact identifier
ndc (package): 50090-4201-0
ndc (product): 50090-4201
ndc11 (package): 50090420100
spl id: b34a6756-91f6-448d-be3f-a40632075df0
spl set id: 8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1
DEBROXCARBAMIDE PEROXIDEMedtech Products Inc.43649ba3-75e0-4dcf-9172-23767dbaeda62025-01-27WarningsExact identifier
ndc (product): 63029-321

Reported adverse events (FAERS/openFDA)#

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