Otc - Active Ingredient
Active ingredien: Sodium Chloride 0.9%
0.9 Percent Saline Solution Liquid
FDA Label NDC 85602-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Empire Groups Llc for the product 0.9 Percent Saline Solution (NDC 85602-101). 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, inactive ingredient, warnings, otc - keep out of reach of children, dosage & administration, indications & usage, otc - purpose, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive ingredien: USP Water
Warnings
Warings:
NOT FOR INJECTION;
Only use sealed vials do not use if vialis broken or already open
Otc - Keep Out Of Reach Of Children
Keep out of reach of children:
Do not use after expiration date;
Discontinue if you experience any adverse reaction and call your physician
Dosage & Administration
Single use dosage vials 5ml each
Indications & Usage
Saline Solution is intended for use in OTC ear,nose,and throat devices intended specifically to administer medicinal substances to treat ear,nose,and throat disorders.These instruments include the powder blower,dropper,ear wick,manual nebulizer pump,and nasal inhaler.
If using with an OTC ear,nose,or throat device,the follow the directions provided with the device and only use as directed.
Otc - Purpose
Uses: Moisturizer
For dry nasal membranes
Otc - Questions
Question:
Package Label.Principal Display Panel
See Label
* Please review the disclaimer below.
