Saline Nasal
FDA Label NDC 76168-701

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma Llc for the product Saline Nasal (NDC 76168-701). 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 active ingredient, purpose, uses, warnings, directions, inactive ingredients, label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium Chloride, 2.65%

Purpose

Nasal Wash to flush allergens and dust from Nasal Passages

Uses

Nasal congestion
Removes inhaled irritants (dust, dirt, pollen)
Moisturizes dry nasal passages

Warnings

Do not use if seal is broken or missing.

Directions

  • Squeeze twice in each nostril as needed
  • Upright delivers a spray, horizontally a stream, upside down a drop
  • Take care not to aspirate nasal contents back into bottle
  • If spray tip touches nose, rinse with hot water before replacing cap

Inactive Ingredients

A hypertonic solution of purified water, potassium phosphate/Sodium
hydroxide buffer, disodium ethylenediaminetetraacetic acid, benzalkonium chloride

Label

Untitled (Untitled)

Untitled (Untitled)

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