Sinus Wash Squeeze Bottle Kit
FDA Label NDC 21130-972

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands Llc for the product Sinus Wash Squeeze Bottle Kit (NDC 21130-972). 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 - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

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 ifwashing 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 blockedor 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

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 packetsper 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
  • Dp 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

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