FDA.reportPublic FDA data

Description

Manufacturer
Blue Echo Care LLC
Effective date
2026-05-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:56:51

Label at a glance#

ProductDevice - NebuClear MD Hand-held Rubber Bulb Nebulizer
Active ingredientRACEPINEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Please consult the use section of the OTC bronchodilator drug label approved for use with this device.

Dosage and administration

Connect bulb to solutions cup. Open top of cup, add approved Bronchodilator, close solutions cup. Squeeze bulb vigorously so visible vapor comes from the top. Breathe in slowly until approved Bronchodilator is gone. Disconnect bulb and follow Cleaning Instructions.

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

This device is a non-sterile hand-held rubber bulb nebulizer intended to aerosolize bronchodilators for inhalation.

This product is listed and approved for over-the-counter use under Monograph M012.

This product contains no active or inactive ingredients.

Uses

INDICATIONS & USAGE SECTION

Please consult the use section of the OTC bronchodilator drug label approved for use with this device.

Warnings

WARNINGS SECTION

Please consult the warnings secton for the OTC bronchodilator drug label before use with this device.

OTC - PURPOSE SECTION

Please consult the purpose section of the OTC bronchodilator drug label approved for use with this device.

INACTIVE INGREDIENT SECTION

This is the device only and includes no active or inactive ingredients.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of small children

Directions

DOSAGE & ADMINISTRATION SECTION

  • Connect bulb to solutions cup.
  • Open top of cup, add approved Bronchodilator, close solutions cup.
  • Squeeze bulb vigorously so visible vapor comes from the top.
  • Breathe in slowly until approved Bronchodilator is gone.
  • Disconnect bulb and follow Cleaning Instructions.

Cleaning Instructions

CLEANING, DISINFECTING, AND STERILIZATION INSTRUCTIONS

  • Soak solutions cup in warm, soapy water for 10 minutes.
  • Rinse in warm water.
  • Let air dry.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Device - Hand-held Bulb NebuizerDevice - Hand-held Bulb Nebuizer

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73117-509-01Device - NebuClear MD Hand-held Rubber Bulb Nebulizer1 mL in 1 BOTTLE, SPRAYSOLUTION14

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
73117-50973117-509-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
RACEPINEPHRINE HYDROCHLORIDE336096P2WEACTIM
EDETATE DISODIUM7FLD91C86KIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-11-18monthly-update2026-06-03 17:45:06

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
Device - NebuClear MD Hand-held Rubber Bulb NebulizerDEVICE - HAND-HELD RUBBER BULB NEBULIZERBlue Echo Care LLC43e0a646-be57-1024-e063-6394a90a43e42026-05-11WarningsExact identifier
ndc (package): 73117-509-01
ndc (product): 73117-509
ndc11 (package): 73117050901
spl id: 5197a04f-a42a-7c51-e063-6394a90a9214
spl set id: 43e0a646-be57-1024-e063-6394a90a43e4

Reported adverse events (FAERS/openFDA)#

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