DEVICE - NEBUCLEAR MD HAND-HELD RUBBER BULB NEBULIZER- device - hand-held rubber bulb nebulizer aerosol, spray

Device - NebuClear MD Hand-held Rubber Bulb Nebulizer by

Drug Labeling and Warnings

Device - NebuClear MD Hand-held Rubber Bulb Nebulizer by is a Otc medication manufactured, distributed, or labeled by Blue Echo Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description

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

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

Warnings

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

PURPOSE

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

INACTIVE INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of small children

Directions

• 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEVICE - NEBUCLEAR MD HAND-HELD RUBBER BULB NEBULIZER 
device - hand-held rubber bulb nebulizer aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73117-521
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RACEPINEPHRINE HYDROCHLORIDE (UNII: 336096P2WE) (EPINEPHRINE,(+/-)- - UNII:GR0L9S3J0F)	EPINEPHRINE,(+/-)-	11.25 mg  in 0.5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73117-521-23	1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/18/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/18/2025

Labeler - Blue Echo Care LLC (117048847)

Establishment
Name	Address	ID/FEI	Business Operations
Blue Echo Care LLC		117048847	manufacture(73117-521)