SPL v1
SPL
SPL Set ID 3f85fe62-230f-b0f1-e063-6394a90a5cb8
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (9 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01

Description

.9% Sodium Chloride


Medication Information

Warnings and Precautions

see a doctor if you:

  • Get worse
  • Need more than 12 inhalations in 24 hours
  • Use more than 9 inhalations in 24 hours for 3 or more days a week
  • Ever been hospitalized for asthma
  • Heart disease
  • High blood pressure
  • Diabetes
  • Thyroid disease
  • Seizures
Indications and Usage

For moistening of the nasal, throat and lungs

Description

.9% Sodium Chloride

Section 50565-1

Keep out of reach of children.

Section 51727-6

water

Section 51945-4

Contains 20 NebuClear MD® Saline vials

Section 53413-1

1 (855) 860-3404

[email protected]

Monday through Friday, 8:00 a.m. to 5:00 p.m. (Pacific Standard Time).

Manufactured By:



Blue Echo Care LLC

3639 SE 21st Ave

Portland, OR 97202 USA

Section 55105-1

Saline for Inhalation

Section 55106-9

.9% Sodium Chloride

Section 60561-8

Protect from light. Avoid excessive heat. Protect from freezing.

Store between 2°C and 25°C (36°F and 77°F).

How Supplied: NebuClear MD® Saline Solution, .9$ Sodium Chloride, 5mL vials

20 vials

Directions
  • Do not use more than directed
  • For use with a Nebulizer.
  • Add 0.5 mL (contents of one vial) of solution to Nebulizer.

Structured Label Content

Indications and Usage (34067-9)

For moistening of the nasal, throat and lungs

Warnings and Precautions (34071-1)

see a doctor if you:

  • Get worse
  • Need more than 12 inhalations in 24 hours
  • Use more than 9 inhalations in 24 hours for 3 or more days a week
  • Ever been hospitalized for asthma
  • Heart disease
  • High blood pressure
  • Diabetes
  • Thyroid disease
  • Seizures
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

water

Section 51945-4 (51945-4)

Contains 20 NebuClear MD® Saline vials

Section 53413-1 (53413-1)

1 (855) 860-3404

[email protected]

Monday through Friday, 8:00 a.m. to 5:00 p.m. (Pacific Standard Time).

Manufactured By:



Blue Echo Care LLC

3639 SE 21st Ave

Portland, OR 97202 USA

Section 55105-1 (55105-1)

Saline for Inhalation

Section 55106-9 (55106-9)

.9% Sodium Chloride

Section 60561-8 (60561-8)

Protect from light. Avoid excessive heat. Protect from freezing.

Store between 2°C and 25°C (36°F and 77°F).

How Supplied: NebuClear MD® Saline Solution, .9$ Sodium Chloride, 5mL vials

20 vials

Directions
  • Do not use more than directed
  • For use with a Nebulizer.
  • Add 0.5 mL (contents of one vial) of solution to Nebulizer.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)