Label: SIMPLY SALINE COMFORT FLOW SINUS WASH- sinus wash powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 70708-270-10, 70708-270-50 - Packager: GURUNANDA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated September 30, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIMPLY SALINE COMFORT FLOW SINUS WASH
sinus wash powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70708-270 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 515 mg in 2200 mg SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 1685 mg in 2200 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Product Characteristics Color white (WHITE CRYSTALLINE GRANULE POWDER) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70708-270-50 50 in 1 BOX 10/01/2022 1 2200 mg in 1 POUCH; Type 1: Convenience Kit of Co-Package 2 NDC:70708-270-10 10 in 1 BOX 09/01/2022 2 2200 mg in 1 POUCH; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/15/2020 Labeler - GURUNANDA, LLC (079671169)