Active Ingredient
Sodium Chloride USP 2300mg
Sodium Bicarbonate USP 700mg
Premixed Saline Packets Granule, For Solution
FDA Label NDC 83879-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Kerui Lnt�l Trading Co., Ltd for the product Premixed Saline Packets (NDC 83879-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, do not use, when using this product, stop use and ask a doctor, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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.
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- (83879 001)
* Please review the disclaimer below.
