OTC Medication Information: SinuCleanse

SINUCLEANSE- sodium bicarbonate and sodium chloride powder, for solution
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.

Active Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

Purpose

Nasal Wash

Uses

Temporarily relieves symptoms associated with

sinusitis, cold, flu or allergies:

-Sneezing

-Runny nose

-Nasal stuffiness

-Post nasal drip

-Removes inhaled irritants (dust, pollen)

-Promotes nasal and sinus drainage

-Helps reduce swelling of nasal membranes

-Moisturizes dry nasal passages

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.

When using this product:

-Use by only one person

-Wash with soap and water after each use

-Top rack of dishwasher safe

-Do not heat in microwave

Keep out of reach of children

Directions

Adults and children 4 years and over: use 1/2 — 1 packet per 4 fl oz (120 mL)up to every two 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 from excessive heat and moisture

-See saline packets or box for lot # and expiration date

Inactive Ingredients

None

Questions?

1-888-547-5492

SINUCLEANSE sodium bicarbonate, sodium chloride powder, for solution

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42829-408 Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 22.2 mg in 100 mg SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 77.8 mg in 100 mg

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42829-408-00 100 PACKET in 1 CARTON contains a PACKET 1 3000 mg in 1 PACKET This package is contained within the CARTON (42829-408-00)

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.