The following Structured Product Label (SPL) was submitted to the FDA by Blue Echo Care Llc for the product Device - Nebuclear Md Hand-held Rubber Bulb Nebulizer (NDC 73117-509). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, uses, warnings, otc - purpose, inactive ingredient, otc - keep out of reach of children, directions, cleaning instructions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Please consult the use section of the OTC bronchodilator drug label approved for use with this device.
Please consult the warnings secton for the OTC bronchodilator drug label before use with this device.
Please consult the purpose section of the OTC bronchodilator drug label approved for use with this device.
This is the device only and includes no active or inactive ingredients.
Keep out of reach of small children
* Please review the disclaimer below.
