Label: SINUCLEANSE- sodium bicarbonate, sodium chloride powder, for solution
- NDC Code(s): 42829-401-01
- Packager: ASCENT CONSUMER PRODUCTS, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 20, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- PURPOSE
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- DOSAGE & ADMINISTRATION
-
SPL UNCLASSIFIED SECTION
Important Note: SinuCleanse Saline Packets contain 3 grams of
pharmaceutical grade salt. Using the calculations in the chart, you can
prepare either an Isotonic or Hypertonic Solution. Since contents of other
manufacturer's Salt Packets may vary, please check with their directions
for Isotonic or Hypertonic use.
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- QUESTIONS
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SINUCLEANSE
sodium bicarbonate, sodium chloride powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42829-401 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 700 mg in 3000 mg SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 2300 mg in 3000 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42829-401-01 3000 mg in 1 PACKET; Type 0: Not a Combination Product 02/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/2015 Labeler - ASCENT CONSUMER PRODUCTS, INC. (078396381)