0.9 Percent Saline Solution

0.9 Percent Saline Solution
SPL v1
SPL
SPL Set ID 33f73db7-ed79-512e-e063-6294a90aca1a
Route
NASAL
Published
Effective Date 2025-04-30
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
UNAPPROVED DRUG OTHER Active Since 2025-04-30
Description

Active ingredien: Sodium Chloride 0.9%

Medication Information

Warnings and Precautions

Warings:

NOT FOR INJECTION;

Only use sealed vials do not use if vialis broken or already open

Indications and Usage

Saline Solution is intended for use in OTC ear,nose,and throat devices intended specifically to administer medicinal substances to treat ear,nose,and throat disorders.These instruments include the powder blower,dropper,ear wick,manual nebulizer pump,and nasal inhaler.

If using with an OTC ear,nose,or throat device,the follow the directions provided with the device and only use as directed.

Dosage and Administration

Single use dosage vials 5ml each

Description

Active ingredien: Sodium Chloride 0.9%

Section 50565-1

Keep out of reach of children:

Do not use after expiration date;

Discontinue if you experience any adverse reaction and call your physician

Section 51727-6

Inactive ingredien: USP Water

Section 51945-4

See Label

Section 53413-1

Question:

[email protected]

Section 55105-1

Uses: Moisturizer

For dry nasal membranes

Section 55106-9

Active ingredien: Sodium Chloride 0.9%

Structured Label Content

Indications and Usage (34067-9)

Saline Solution is intended for use in OTC ear,nose,and throat devices intended specifically to administer medicinal substances to treat ear,nose,and throat disorders.These instruments include the powder blower,dropper,ear wick,manual nebulizer pump,and nasal inhaler.

If using with an OTC ear,nose,or throat device,the follow the directions provided with the device and only use as directed.

Dosage and Administration (34068-7)

Single use dosage vials 5ml each

Warnings and Precautions (34071-1)

Warings:

NOT FOR INJECTION;

Only use sealed vials do not use if vialis broken or already open

Section 50565-1 (50565-1)

Keep out of reach of children:

Do not use after expiration date;

Discontinue if you experience any adverse reaction and call your physician

Section 51727-6 (51727-6)

Inactive ingredien: USP Water

Section 51945-4 (51945-4)

See Label

Section 53413-1 (53413-1)

Question:

[email protected]

Section 55105-1 (55105-1)

Uses: Moisturizer

For dry nasal membranes

Section 55106-9 (55106-9)

Active ingredien: Sodium Chloride 0.9%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:02.294500 · Updated: 2026-03-14T23:08:30.723878