FDA.reportPublic FDA data

Debrox Swimmers Ear

Manufacturer
Medtech Products Inc.
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:40:31

Label at a glance#

ProductDebrox Swimmers Ear
Active ingredientISOPROPYL ALCOHOL
Label structure10 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

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 95% in an anhydrous glycerin 5% base

Purpose

OTC - PURPOSE SECTION

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

OTC - DO NOT USE SECTION

in the eyes

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

OTC - STOP USE SECTION

irritation (too much burning) or pain occurs

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

Inactive Ingredient 

INACTIVE INGREDIENT SECTION

Glycerin

Other information

OTHER SAFETY INFORMATION

  • recap bottle after each use
  • keep away from head or direct sunlight
  • store at room temperature 15-25ºC (59-77ºF)
  • do not use if foil seal imprinted with “SEALED FOR YOUR PROTECTION” under cap is broken or missing
  • keep carton for full drug facts

Questions?

OTC - QUESTIONS SECTION

1-800-344-7239 debrox.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Debrox ® Swimmer’s Ear
Isopropyl alcohol 95%
Ear Drying Drops
1 FL OZ (30 mL)

Debrox ® Swimmer’s Ear Isopropyl alcohol 95% Ear Drying Drops 1 FL OZ (30 mL)Debrox ® Swimmer’s Ear 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 SolutionPSN3
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD3
631799isopropyl alcohol 94.998 % Otic SolutionSY3
631799isopropyl alcohol 95 % Otic SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-323-01Debrox Swimmers Ear30 mL in 1 BOTTLELIQUID303

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
63029-32363029-323-01

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-10-25full-release2026-06-01 00:41:30

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 Swimmers EarISOPROPYL ALCOHOLMedtech Products Inc.b5d57c7b-8315-4260-967e-38fdd54e2a9c2025-10-23WarningsExact identifier
ndc (package): 63029-323-01
ndc (product): 63029-323
ndc11 (package): 63029032301
spl id: 26ccea52-4ce6-4e95-b838-4824523e579c
spl set id: b5d57c7b-8315-4260-967e-38fdd54e2a9c

Reported adverse events (FAERS/openFDA)#

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