Active Ingredients
Sodium Bicarbonate USP 515 mg
Sodium Chloride USP 1685 mg
Simply Saline Comfort Flow Sinus Wash
FDA Label NDC 70708-270
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gurunanda, Llc for the product Simply Saline Comfort Flow Sinus Wash (NDC 70708-270). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal Wash
Uses
- Restores vital moisture to provide prompt relief for dry , crusted and inflamed nasal membranes due to chronic sinusitis, colds, low humidity, overuse of nasal decongestant drops and sprays, allergies, minor nose bleeds and other minor nasal irritations.
- Temporarily relieves nasal stuffiness.
- Reduces swelling of nasal passages; shrinks swollen membranes.
- Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure.
Warnings
- Do not exceed recommended dosage.
- This product may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge.
- The use of this container by more than one person may spread infection.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions
- Adults and children 4 years and over : Use 1-2 packets per 240 ml up to every 2 hours as needed
- Children under 4 years : Consult a physician
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
Inactive Ingredients
None
* Please review the disclaimer below.
