SPL v1
SPL
SPL Set ID dd4e3c58-4cd5-46da-89cd-88ab004c69ae
Route
NASAL
Published
Effective Date 2025-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (49.5 g) Sodium Cation (16.5 g)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-06-17

Description

Sodium Bicarbonate 16.5 g Sodium Chloride 49.5 g 

Purpose

Nasal Wash


Medication Information

Purpose

Nasal Wash

Description

Sodium Bicarbonate 16.5 g Sodium Chloride 49.5 g 

Use

May relieve symptoms associated with

allergies post-nasal drip common cold nasal congestiom

Section 50565-1

Keep out of reach of children

Section 51945-4

Warnings

Stop use and consult consider if washing is uncomfortable after nasal rinsing.

Questions

1-844-777-9301

Directions

Adults and children4 years and over:Use 1-2 packets per 8 ozcontainer every 2 hoursas needed

Children under 4 years:Consult a physician

Read Instructions for Use inside box for proper use

Active Ingredient

Sodium Bicarbonate 16.5 g Sodium Chloride 49.5 g 

Other Information

Inspect saline solution packets for integrity

Do not use if open or tom

Protect saline solurtion packet from excessive heat andmoisture

Inactive Ingredients

none


Structured Label Content

Use

May relieve symptoms associated with

allergies post-nasal drip common cold nasal congestiom

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51945-4 (51945-4)

Purpose

Nasal Wash

Warnings

Stop use and consult consider if washing is uncomfortable after nasal rinsing.

Questions

1-844-777-9301

Directions

Adults and children4 years and over:Use 1-2 packets per 8 ozcontainer every 2 hoursas needed

Children under 4 years:Consult a physician

Read Instructions for Use inside box for proper use

Active Ingredient (Active ingredient)

Sodium Bicarbonate 16.5 g Sodium Chloride 49.5 g 

Other Information (Other information)

Inspect saline solution packets for integrity

Do not use if open or tom

Protect saline solurtion packet from excessive heat andmoisture

Inactive Ingredients (Inactive ingredients)

none


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)