Label: SINUCLEANSE SQUEEZE- sodium bicarbonate, sodium chloride kit
- NDC Code(s): 42829-401-01, 42829-405-30
- 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.
Drug Label Information
Updated January 17, 2024
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
- OTHER SAFETY INFORMATION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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INSTRUCTIONS FOR USE
Instructions for Use of the SinuCleanse Squeeze
Directions: Read through entire section before using for the first time.
1. Remove the cap from the SinuCleanse Squeeze bottle.
2. Pour the pre-mixed saline dry ingredients into the SinuCleanse Squeeze
Bottle. First-time users should start with 1 packet of the saline dry
ingredients. As you become more accustomed to the system, work up
to using 2 full packets. Additional packets may be purchased from your
nearest pharmacy.
3. Fill the bottle with a proper water source * leaving approximately 1/2 inch
of air at the top of the bottle. This makes 1 cup ( 8 oz. ) of solution.
4. Tighten the cap on the bottle securely, place one finger over the tip of the cap and gently
shake the bottle until the dry ingredients have completely dissolved.
5. Lean over the sink with your head bent down so you are looking directly into the basin. Place
the tip of the cap up to the right nostril and gently insert the tip so that it forms a comfortable
seal. Aim the tip at the back of your head, not at the top of your head.
6. Squeeze the bottle gently so that the solution enters the right nostril. Do not inhale or "snort"
the solution into the nose - breathe through your mouth.
7. In a few moments the solution will begin to drain out of the left nostril. Continue to squeeze
the bottle gently until you have used approximately half of the solution.
8. Remove the tip of the bottle from your nostril, then exhale through both nostrils
to clear them of excess mucus and solution. Gently blow your nose into a tissue.
9. Repeat the procedure on the left nostril with the remaining solution.
10. A small amount of solution will remain at the bottom of the bottle. Discard the
remaining solution.
11. Thoroughly rinse the bottle after each use with water that has been distilled,
sterilized, filtered or previously boiled and leave the bottle open to air dry
completely. The SinuCleanse Squeeze Bottle is also top-rack dishwasher safe.
Hints for a more comfortable nasal wash
- Begin using the SinuCleanse System slowly. A full pot or bottle of solution
on each side is not necessary to receive the full benefit.
-If the solution is too warm or too cold, the nasal wash will be uncomfortable.
-If stinging or irritation occurs, try using 1/2 of a packet of dry ingredients for the Neti
Pot or 1 packet per Squeeze Bottle of the saline dry ingredients. Gradually work up
to using the solution at full strength. Do not use less than 1/2 packet for the Neti Pot
or 1 packet per Squeeze bottle.
-If you experience ear discomfort after use, try to blow your nose more gently after the
wash. If the problem persists, the openings of your Eustachian tubes may be
particularly wide and the use of the SinuCleanse System may need
to be discontinued.
-Breathe continuously through the mouth when using the SinuCleanse system
to avoid solution draining from the back of the nose into the mouth.
-Some people experience irritation of the skin just insdie the nostrils with repeated
nasal washing. Applying a thin layer of aloe to the inside of the nostrils before or after
the nasal wash will be soothing.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SINUCLEANSE SQUEEZE
sodium bicarbonate, sodium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42829-405 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42829-405-30 1 in 1 KIT 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 solutionProduct 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)
