Otc - Active Ingredient
Active ingredients
(in each packet)
Sodium Bicarbonate USP (700 mg)
Sodium Chloride USP (2300 mg)
The following Structured Product Label (SPL) was submitted to the FDA by Foodhold U.s.a. for the product All Natural Saline Packets (NDC 41520-938). 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 otc - active ingredient, otc - purpose, indications & usage, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
(in each packet)
Sodium Bicarbonate USP (700 mg)
Sodium Chloride USP (2300 mg)
Purpose
Nasal Wash
Uses
Temporarily relieves symptoms associated with
sinusitis, cold, flu or allergies
-Sneezing
-Nasal stuffiness
-Runny nose
-Post nasal drip
Removes inhaled irritants (dust, pollen)
Removes nasal and sinus drainage
Helps reduce swelling of nasal membranes
Moisturizes dry nasal passages
Keep out of reach of children
Warnings
Stop use and ask a doctor if washing is uncomfortable or symptoms are not relieved.
Do not use unfiltered tap water. see instructions inside box for proper water sources
Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears
Directions
Adults and children 4 years and over: Use 1-2 packetsĀ per 8 fl oz (240 mL) up to every 2 hours as needed.
Children under 4 years: Consult a physician
See enclosed instruction sheet for complete directions and proper use.
Inactive ingredients
None
Other Information
-Inspect saline packets for integrity
-Do not use saline packets if open or torn
-Protect saline packets from excessive heat and moisture
-See saline packets or box for lot # and expiration date
-See instruction sheet for use
Questions?
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