Label: PREMIXED SALINE PACKETS- sodium chloride, sodium bicarbonate granule, for solution
- NDC Code(s): 83879-001-01
- Packager: Shenzhen Kerui lnt’l Trading Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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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
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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.
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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
- Inactive ingredients
- Label
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INGREDIENTS AND APPEARANCE
PREMIXED SALINE PACKETS
sodium chloride, sodium bicarbonate granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83879-001 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 700 mg in 3000 mg SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 2300 mg in 3000 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83879-001-01 100 in 1 BOX 12/22/2023 1 3000 mg in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/22/2023 Labeler - Shenzhen Kerui lnt’l Trading Co., Ltd (699692787) Establishment Name Address ID/FEI Business Operations Shenzhen Kerui Int'l trading co., ltd. 699692787 label(83879-001) , manufacture(83879-001)
