3 percent saline solution

Manufacturer
EMPIRE GROUPS LLC | Guangzhou Jinsheng Biotechnology Corporation
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:46:43

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredien: Sodium Chloride 3%

OTC - PURPOSE SECTION

Uses: Moisturizer For dry nasal membranes

Uses

INDICATIONS & USAGE SECTION

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.

Warnings

WARNINGS SECTION

Warings: NOT FOR INJECTION; Only use sealed vials do not use if vialis broken or already open

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Single use dosage vials 5ml each

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive ingredien: USP Water

OTC - QUESTIONS SECTION

Question: emipregrp@gmail.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See Label

Label Images#

Label 3
Label 3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85602-10285602-102-01, 85602-102-02

Ingredients#

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XACTIB

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredien: Sodium Chloride 3%

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredien: USP Water

WARNINGS SECTION

WARNINGS SECTION

Warings: NOT FOR INJECTION; Only use sealed vials do not use if vialis broken or already open

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

DOSAGE & ADMINISTRATION SECTION

Single use dosage vials 5ml each

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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 SECTION

OTC - PURPOSE SECTION

Uses: Moisturizer For dry nasal membranes

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Question: emipregrp@gmail.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See Label

Source Document#

Source XML