Sinucleanse Neti-pot Kit
FDA Label NDC 42829-402

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 Neti-pot (NDC 42829-402). 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 - purpose, indications & usage, otc - keep out of reach of children, warnings, dosage & administration, other safety information, otc - active ingredient, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - 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

Otc - 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 from excessive heat and moisture

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

Questions?

1-888-547-5492

Otc - 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 Neti Pot

Directions: Read through entire section before using for the first time.

1. Empty the contents of one SinuCleanse Saline Wash packet into the

SinuCleanse Neti Pot. First-time users should start with 1/2 packet of

the SinuCleanse dry ingredients. As you become more accustomed to

the system, work up to using 1 full packet. Additional packets may be

purchased from your nearest pharmacy.

2. Fill the pot halfway or to the middle of the indentation with a proper water source.*

This makes 1/2 cup (4 oz. ) solution.

3. Stir thoroughly until dry ingredients have completely dissolved.

4. Proper head position allows solution to flow through the nose by gravity.

    - Lean over the sink with your head bent down so you are looking directly into the basin.

    Holding the pot in your right hand, gently insert the spout into your right nostril so that it

    forms a comfortable seal.

    - Rotate your head so that the right nostril is directly above the left. The forehead should

    remain higher than the chin. Raise the handle of the pot so that the solution enters the right

    nostril. In a few moments, the solution will begn to drain out the left nostril into the sink.

    Do not inhale or "snort" solution into the nose - breathe through your mouth.

5. When the pot i empty, exhale through both nostrils to clear them

of excess mucus and solution. Gently blow your nose into a tissue.

6. Repeat the procedure on the other side.

7. Thoroughly rinse the pot after each use with water that has

been distilled, sterilized, filtered or previously boiled and leave the

pot to air dry completely. The SinuCleanse Neti Pot is top-rack dishwasher safe.

Package Label.Principal Display Panel

Copy Of Label (Pot Label)

Copy Of Label (Pot Label)

* Please review the disclaimer below.