SINUCLEANSE- sodium bicarbonate, 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.

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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 -1 packet  per 4 fl oz (120 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.

Important Note: SinuCleanse Saline Packets contain 3 grams of

pharmaceutical grade salt. Using the calculations in the chart, you can

prepare either an Isotonic or Hypertonic Solution. Since contents of other

manufacturer's Salt Packets may vary, please check with their directions

for Isotonic or Hypertonic use.

Active ingredients

(in each packet)

Sodium Bicarbonate USP (700 mg)

Sodium Chloride USP (2300 mg)

Inactive ingredients

None

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

Questions?

1-888-547-5492

-See enclosed instruction sheet for complete directions and proper use


copy of label

SINUCLEANSE 
sodium bicarbonate, sodium chloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42829-401
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE700 mg  in 3000 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2300 mg  in 3000 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42829-401-013000 mg in 1 PACKET; Type 0: Not a Combination Product02/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2015
Labeler - ASCENT CONSUMER PRODUCTS, INC. (078396381)

Revised: 2/2021
Document Id: bbccd2ce-d9af-fb70-e053-2a95a90aa9bf
Set id: c33bf872-54aa-45e0-9e40-a6565a13f198
Version: 6
Effective Time: 20210220
 
ASCENT CONSUMER PRODUCTS, INC.