FDA.reportPublic FDA data

Debrox Kids

Manufacturer
Medtech Products Inc.
Effective date
2024-05-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:13:15

Label at a glance#

ProductDebrox Kids
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Dosage and administration

unscrew cap from bottle remove foil safety seal from bottle affix applicator cap to bottle remove red applicator cap tip apply 4 to 5 drops in each affected ear

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Purpose

OTC - PURPOSE SECTION

Isopropyl alcohol 95% in an anhydrous glycerin 5% base ....Ear drying aid

Use

INDICATIONS & USAGE SECTION

dries water in the ears and relieves water-clogged ears after

  • swimming
  • showering
  • bathing
  • washing the hair

Warnings

WARNINGS SECTION

Flammable: Keep away from fire or flame

Do not use in the eyes.

OTC - DO NOT USE 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

• recently had ear surgery

Stop use and ask a doctor if irritation (too much burning) or pain occurs

OTC - STOP USE SECTION

Keep out of 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

  • unscrew cap from bottle
  • remove foil safety seal from bottle
  • affix applicator cap to bottle
  • remove red applicator cap tip
  • apply 4 to 5 drops in each affected ear

Other information

OTHER SAFETY INFORMATION

  • recap bottle after each use
  • keep away from heat or direct sunlight
  • store at room temperature 15-25ºC (59-77ºF)

Inactive

INACTIVE INGREDIENT SECTION

Glycerin

Questions?

OTC - QUESTIONS SECTION

1-800-344-7239 debrox.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Debrox ® Kids

Isopropyl alcohol 95%

Ear Drying Drops

1 FL OZ (30 mL)

PRINCIPAL DISPLAY PANEL Debrox ® Kids Isopropyl alcohol 95% Ear Drying Drops 1 FL OZ (30 mL)PRINCIPAL DISPLAY PANEL Debrox ® Kids Isopropyl alcohol 95% Ear Drying Drops 1 FL OZ (30 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN2
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD2
631799isopropyl alcohol 94.998 % Otic SolutionSY2
631799isopropyl alcohol 95 % Otic SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-325-01Debrox Kids1 in 1 CARTONLIQUID12
63029-325-01Debrox Kids30 mL in 1 BOTTLELIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-325DEBROX KIDS (ISOPROPYL ALCOHOL) LIQUID [MEDTECH PRODUCTS INC.]2Current NDC, 2 package rows20240601_f42eee70-c4ee-44ad-85d5-a06d98ecb8b0.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-32563029-325-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
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
Debrox KidsISOPROPYL ALCOHOLMedtech Products Inc.f42eee70-c4ee-44ad-85d5-a06d98ecb8b02024-05-09WarningsExact identifier
ndc (package): 63029-325-01
ndc (product): 63029-325
ndc11 (package): 63029032501
spl id: 1b8b21f4-8317-4f77-94c6-ba5bc6b5dd96
spl set id: f42eee70-c4ee-44ad-85d5-a06d98ecb8b0

Reported adverse events (FAERS/openFDA)#

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