OTC Medication Information: SinuCleanse Squeeze

SINUCLEANSE SQUEEZE- sodium bicarbonate, sodium chloride
ASCENT CONSUMER PRODUCTS, INC.

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.

Purpose

Nasal Wash

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

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.

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 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 ingredients

(in each packet)

Sodium Bicarbonate USP (700 mg)

Sodium Chloride USP (2300 mg)

Inactive Ingredients

None

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.

copy of label
(click image for full-size original)

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 Multilevel Packaging
1 NDC:42829-405-30 1 KIT in 1 KIT None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 2300 mg in 3000 mg
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 700 mg in 3000 mg
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42829-401-01 3000 mg in 1 PACKET None
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)

Revised: 02/2021 ASCENT CONSUMER PRODUCTS, INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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