SINUCLEANSE NETI-POT- sodium bicarbonate, sodium chloride kit

SinuCleanse Neti-Pot by

Drug Labeling and Warnings

SinuCleanse Neti-Pot by is a Otc medication manufactured, distributed, or labeled by ASCENT CONSUMER PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Purpose

Nasal Wash

INDICATIONS & USAGE

Uses

Temporarily relieves symptoms associated with

sinusitis, cold, flu or allergies

-Sneezing

-Nasal Stuffiness

-Runny nose

-Post nasal drip

Removes inhaled irritants (dust, pollen)

Removes nasal and sinus drainage

Helps reduce swelling of nasal membranes

Moisturizes dry nasal passages

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

WARNINGS

Warnings

Stop use and ask a doctor if washing is uncomfortable

or symptoms are not relieved.

Do not use unfiltered tap water. see instructions inside box for proper water sources

Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears.

DOSAGE & ADMINISTRATION

Directions

Adults and children 4 years and over: Use 1-2 packets per 8 fl oz (240 mL) up to every 2 hours as needed.

Children under 4 years: Consult a physician

See enclosed instruction sheet for complete directions and proper use.

OTHER SAFETY INFORMATION

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 number and expiration date

Questions?

1-888-547-5492

ACTIVE INGREDIENT

Active ingredients

(in each packet)

Sodium Bicarbonate USP (700 mg)

Sodium Chloride USP (2300 mg)

INACTIVE INGREDIENT

Inactive Ingredients

None

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

SINUCLEANSE NETI-POT 
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)

Establishment
Name	Address	ID/FEI	Business Operations
ASCENT CONSUMER PRODUCTS, INC.		078396381	manufacture(42829-402)