Saline Spray
FDA Label NDC 68163-704

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuiticals Inc for the product Saline (NDC 68163-704). 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 ingredients, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Sodium Chloride 0.65%

Purpose

Moisturizer

Uses

Naturally provides instant, soothing relief dry irritated nasal passages due to colds, allergies, dry air, pollution, smoke, air travel and use of decongestants/steroidal sprays.

Warnings

If pregnant or breast-feeding, ask a healthcare professional before use. Use of this container by more than one person may spread infection.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions

For children and adults, squeeze bottle twice in each nostril as often as needed or as directed by physician. For infants, use drop application. Hold bottle upright for spray, horizontally for stream, and upside down for drop. The use of this dispenser by more than one person may spread infection.

Other Information

store at room temperature

Inactive Ingredients

benzalkonium chloride, benzyl alcohol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Questions Or Comments?

1-866-467-2748

*This product is not manufactured or distributed by Valeant Pharmaceuticals North America LLC, sodium phosphate monobasic.

Saline Nasal Spray

FAMILY wellness™

Compare to the active ingredient in Ocean®*

NDC: 68163-704-15

Saline Nasal Spray

Sodium Chloride 0.65%

Instantly relieves dry nasal passages caused by sinus, cold and allergy medications and dry air

Safe for frequent daily use

Gentle enough for infants

Natural, non-medicated relief for stuffy noses

100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

1.5 FL O.Z. (44 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL AROUND CAP IS BROKEN OR MISSING.

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