Otc - Active Ingredient
Active Ingredients
(in each packet)
Sodium Bicarbonate USP 700 mg
Sodium Chloride USP 2300 mg
Sinucleanse Powder, For Solution
FDA Label NDC 42829-408
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ascent Consumer Products, Inc. for the product Sinucleanse (NDC 42829-408). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Nasal Wash
Indications & Usage
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
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.
Otc - When Using
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Dosage & Administration
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 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 # and expiration date
Inactive Ingredient
Inactive Ingredients
None
Otc - Questions
Questions?
1-888-547-5492
Package Label.Principal Display Panel
Copy Of Label (Ascent60 Label)
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