Otc - Purpose
Cleaning solution
0.9%saline Solution
FDA Label NDC 87311-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Huizhou Jinsheng Medical Technology Co., Ltd for the product 0.9%saline (NDC 87311-103). 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 - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, otc - active ingredient, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
Usage: This product is designed for gentle cleaning of the face, mouth, nose, eyes, ears, and wounds. It can also be used with a nebulizer to help relieve discomfort in the nose and mouth.
Warnings
Warnings:
1.Apply the cleaning solution to the area to be cleaned.
2.The product comes in single-use vials, 5 mL each.
3.Not for injection.
4.Do not share or reuse.
5.Keep out of reach of children.
6.Do not use if allergic to any of stated Ingredients, if irritation occurs, discontinue use and consult your doctor or specialist.
7.Use within 24 hours after opening.
8.This product is not a substitute for medication or medical devices.
Dosage & Administration
Single use dosage vials 5ml each
Otc - Active Ingredient
Active ingredient: Sodium Chloride 0.9%
Inactive Ingredient
Inactive ingredient: USP Water
Other Safety Information
Pay Attention: Do not use if the product is damaged or leaking.
Otc - Questions
Manufacturer:
Huizhou Jinsheng Medical Technology Co., Ltd
Luangang Dahu, Shiwan Mingyue 2nd Road, Boluo County, Huizhou, Guangdong, China, 516000
Storage And Handling
Storage:Store at room temperature.Avoid freezing or excessive heat.
Package Label.Principal Display Panel
See Label
* Please review the disclaimer below.
