Label: SINUCLEANSE NETI-POT- sodium bicarbonate, sodium chloride kit
- NDC Code(s): 42829-401-01, 42829-402-30
- Packager: ASCENT CONSUMER PRODUCTS, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated February 22, 2021
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- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
INSTRUCTIONS FOR USE
Instructions for Use of the SinuCleanse Neti Pot
Directions: Read through entire section before using for the first time.
1. Empty the contents of one SinuCleanse Saline Wash packet into the
SinuCleanse Neti Pot. First-time users should start with 1/2 packet of
the SinuCleanse dry ingredients. As you become more accustomed to
the system, work up to using 1 full packet. Additional packets may be
purchased from your nearest pharmacy.
2. Fill the pot halfway or to the middle of the indentation with a proper water source.*
This makes 1/2 cup (4 oz. ) solution.
3. Stir thoroughly until dry ingredients have completely dissolved.
4. Proper head position allows solution to flow through the nose by gravity.
- Lean over the sink with your head bent down so you are looking directly into the basin.
Holding the pot in your right hand, gently insert the spout into your right nostril so that it
forms a comfortable seal.
- Rotate your head so that the right nostril is directly above the left. The forehead should
remain higher than the chin. Raise the handle of the pot so that the solution enters the right
nostril. In a few moments, the solution will begn to drain out the left nostril into the sink.
Do not inhale or "snort" solution into the nose - breathe through your mouth.
5. When the pot i empty, exhale through both nostrils to clear them
of excess mucus and solution. Gently blow your nose into a tissue.
6. Repeat the procedure on the other side.
7. Thoroughly rinse the pot after each use with water that has
been distilled, sterilized, filtered or previously boiled and leave the
pot to air dry completely. The SinuCleanse Neti Pot is top-rack dishwasher safe.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
sodium bicarbonate, sodium chloride kit
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42829-402 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42829-402-30 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 02/01/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 30 PACKET 90000 mg Part 1 of 1 SINUCLEANSE
sodium bicarbonate, sodium chloride powder, for solution
Product Information Item Code (Source) NDC:42829-401 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 2300 mg in 3000 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 700 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 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2013 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)