SINUCLEANSE SQUEEZE- sodium bicarbonate, sodium chloride kit

SinuCleanse Squeeze by

Drug Labeling and Warnings

SinuCleanse Squeeze 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 form 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 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 kit

Product 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 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(42829-405)