Leader Sinus Wash Saline Refill Packets Powder, For Solution
FDA Label NDC 70000-0270

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, 110 Dba Leader for the product Leader Sinus Wash Saline Refill Packets (NDC 70000-0270). 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, otc - keep out of reach of children, warnings, dosage & administration, other safety information, otc - questions, 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

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 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 sheetfor 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

Otc - Questions

Questions?

1-888-547-5492

Spl Patient Package Insert

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Inactive Ingredient

Inactive Ingredients

None

Package Label.Principal Display Panel

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