83879-001-01

Drug Facts

Composition & Product

Active Ingredients

Bicarbonate Ion (700 mg) Chloride Ion (2300 mg)

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2023-12-22

Medication Information

Purpose

Nasal Wash

Description

Sodium Chloride USP 2300mg Sodium Bicarbonate USP 700mg

Uses

Relieve Nasal Passages From:

■Nasal symptoms from sinusitis, cold, flu ■Nasal allergies, dryness and Hay fever ■Sneezing, runny nose, nasal stuffiness

■lPost nasal drip and nasal congestion ■Removes nasal irritants (dust, pollen, animal dander, smoke etc)

■Promotes nasal and sinus drainage l■Moisturizes dry nasal passages ■Helps reduce swelling of nasal membranes

Label

Directions

Adults and children 4 years and over:	use 1-2 packets per 8 fl oz (240ml) up to every 2 hours as needed
Children under 4 years:	Consult a physician
Mixing one saline packet to 8 fl oz (240ml) of water creates an Isotonic saline solution (Hypertonic with 2 saline packets) that is PH balanced and preservative free.
Isotonic solution	1 saline packet per 8 fl oz (240 ml)
Hypertonic solution	2 saline packets per 8 fl oz (240 ml)
An Isotonic solution has a gentle salt concentration of 9 mg of Sodium Chloride per ml of water, similar to your body's salt level. It can be more comfortable for some initially than a stronger Hypertonic solution. A Hypertonic solution has a higher salt concentration, akin to ocean water's salt content.

Do Not Use

■ if saline packet is open, torn, or expired.

■ with fully blocked nasal passages or during ear infection or blockage.

■ unfiltered tap water, unless it has been previously boiled for at least five minutes and then cooled to lukewarm or body temperature, as boiling sterilizes the water. Other choice are distilled, micro-filtered (through 0.2 micron), reverse osmosis filtered, or commercially bottled water.

Active Ingredient

Sodium Chloride USP 2300mg

Sodium Bicarbonate USP 700mg

Other Information

Store in a cool and dry place.

Inactive Ingredients

None

When Using This Product

Wash hands before using

Stop Use and Ask A Doctor

if discomfort or unrelieved symptoms occur.

Structured Label Content

Uses

Relieve Nasal Passages From:

■Nasal symptoms from sinusitis, cold, flu ■Nasal allergies, dryness and Hay fever ■Sneezing, runny nose, nasal stuffiness

■lPost nasal drip and nasal congestion ■Removes nasal irritants (dust, pollen, animal dander, smoke etc)

■Promotes nasal and sinus drainage l■Moisturizes dry nasal passages ■Helps reduce swelling of nasal membranes

Label

Purpose

Nasal Wash

Directions

Adults and children 4 years and over:	use 1-2 packets per 8 fl oz (240ml) up to every 2 hours as needed
Children under 4 years:	Consult a physician
Mixing one saline packet to 8 fl oz (240ml) of water creates an Isotonic saline solution (Hypertonic with 2 saline packets) that is PH balanced and preservative free.
Isotonic solution	1 saline packet per 8 fl oz (240 ml)
Hypertonic solution	2 saline packets per 8 fl oz (240 ml)
An Isotonic solution has a gentle salt concentration of 9 mg of Sodium Chloride per ml of water, similar to your body's salt level. It can be more comfortable for some initially than a stronger Hypertonic solution. A Hypertonic solution has a higher salt concentration, akin to ocean water's salt content.

Do Not Use (Do not use)

■ if saline packet is open, torn, or expired.

■ with fully blocked nasal passages or during ear infection or blockage.

■ unfiltered tap water, unless it has been previously boiled for at least five minutes and then cooled to lukewarm or body temperature, as boiling sterilizes the water. Other choice are distilled, micro-filtered (through 0.2 micron), reverse osmosis filtered, or commercially bottled water.

Active Ingredient (Active ingredient)

Sodium Chloride USP 2300mg

Sodium Bicarbonate USP 700mg

Other Information (Other information)

Store in a cool and dry place.

Inactive Ingredients (Inactive ingredients)

None

When Using This Product (When using this product)

Wash hands before using

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if discomfort or unrelieved symptoms occur.

Advanced Ingredient Data

[{"name": "BICARBONATE ION", "unii": "HN1ZRA3Q20", "classCode": "ACTIB", "strengthNumerator": "700", "strengthDenominator": "3000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "CHLORIDE ION", "unii": "Q32ZN48698", "classCode": "ACTIB", "strengthNumerator": "2300", "strengthDenominator": "3000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Relieve Nasal Passages From: ■Nasal symptoms from sinusitis, cold, flu ■Nasal allergies, dryness and Hay fever ■Sneezing, runny nose, nasal stuffiness ■lPost nasal drip and nasal congestion ■Removes nasal irritants (dust, pollen, animal dander, smoke etc) ■Promotes nasal and sinus drainage l■Moisturizes dry nasal passages ■Helps reduce swelling of nasal membranes", "Purpose": "Nasal Wash", "Directions": "Adults and children 4 years and over: use 1-2 packets per 8 fl oz (240ml) up to every 2 hours as needed Children under 4 years: Consult a physician Mixing one saline packet to 8 fl oz (240ml) of water creates an Isotonic saline solution (Hypertonic with 2 saline packets) that is PH balanced and preservative free. Isotonic solution 1 saline packet per 8 fl oz (240 ml) Hypertonic solution 2 saline packets per 8 fl oz (240 ml) An Isotonic solution has a gentle salt concentration of 9 mg of Sodium Chloride per ml of water, similar to your body's salt level. It can be more comfortable for some initially than a stronger Hypertonic solution. A Hypertonic solution has a higher salt concentration, akin to ocean water's salt content.", "Do not use": "■ if saline packet is open, torn, or expired. ■ with fully blocked nasal passages or during ear infection or blockage. ■ unfiltered tap water, unless it has been previously boiled for at least five minutes and then cooled to lukewarm or body temperature, as boiling sterilizes the water. Other choice are distilled, micro-filtered (through 0.2 micron), reverse osmosis filtered, or commercially bottled water.", "Active ingredient": "Sodium Chloride USP 2300mg Sodium Bicarbonate USP 700mg", "Other information": "Store in a cool and dry place.", "Inactive ingredients": "None", "When using this product": "Wash hands before using", "Stop use and ask a doctor": "if discomfort or unrelieved symptoms occur."}