Saline Nasal
FDA Label NDC 58599-036

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Purinepharma Llc for the product Saline Nasal (NDC 58599-036). 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 - ask doctor, otc - do not use, otc - keep out of reach of children, dosage & administration, 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 Ingredient: Sodium Chloride 0.65%

Otc - Purpose

For allergies, cold, flu, sinusitis, rhinitis and dry irritated nasal passages

Indications & Usage

Indications: For relief of dry nasal passages caused by sinus, cold and allergy medications, nasal surgery and dry air. Also relieves congestion by thinning mucus.

Otc - Ask Doctor

WARNING:
If pregnant or breast feeding, ask a health professional before use.

Otc - Do Not Use

Use of this container by more than one person may spread infection.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Centre right away.

Dosage & Administration

Directions: For children and adults, squeeze bottle twice in each nostril as often as needed or as directed by doctor. For infants, use drop application. Hold bottle upright for spray, horizontally for stream and upside down for drop.

Inactive Ingredient

INGREDIENTS:
Sodium phosphate dibasic and sodium phosphate monobasic, with benzyl alcohol and benzalkonium chloride as preservatives.

Package Label.Principal Display Panel

Made in USA

Manufactured by Purinepharma LLC
Massena, NY 13662 U.S.A.
 *This product is not manufactured or distributed by Valeant Consumer Products, distributors of Ocean Saline Nasal Spray

44ml (Label1)

44ml (Label1)

* Please review the disclaimer below.