PREMIXED SALINE PACKETS- sodium chloride, sodium bicarbonate granule, for solution 
Shenzhen Kerui lnt’l Trading Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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83879-001-01

Active ingredient

Sodium Chloride USP 2300mg

Sodium Bicarbonate USP 700mg

Purpose

Nasal Wash

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

Warnings

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.

When using this product

Wash hands before using

Stop use and ask a doctor

if discomfort or unrelieved symptoms occur.

Keep out of reach of children.

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.

Other information

Store in a cool and dry place.

Inactive ingredients

None

Label

001-

PREMIXED SALINE PACKETS 
sodium chloride, sodium bicarbonate granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83879-001
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE700 mg  in 3000 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE2300 mg  in 3000 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83879-001-01100 in 1 BOX12/22/2023
13000 mg in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/22/2023
Labeler - Shenzhen Kerui lnt’l Trading Co., Ltd (699692787)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen Kerui Int'l trading co., ltd.699692787label(83879-001) , manufacture(83879-001)

Revised: 12/2023
Document Id: 0d11e07b-c138-6efc-e063-6394a90a6bba
Set id: 0d11e07b-c137-6efc-e063-6394a90a6bba
Version: 1
Effective Time: 20231221
 
Shenzhen Kerui lnt’l Trading Co., Ltd