3 percent saline solution

3 percent saline solution by

Drug Labeling and Warnings

3 percent saline solution by is a Otc medication manufactured, distributed, or labeled by EMPIRE GROUPS LLC, Guangzhou Jinsheng Biotechnology Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

3 PERCENT SALINE SOLUTION- sodium chloride liquid 
EMPIRE GROUPS LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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3 percent saline solution

Active ingredien: Sodium Chloride 3%

Inactive ingredien: USP Water

Warings:

NOT FOR INJECTION;

Only use sealed vials do not use if vialis broken or already open

Keep out of reach of children:
Do not use after expiration date;
Discontinue if you experience any adverse reaction and call your physician

Single use dosage vials 5ml each

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.

Uses: Moisturizer

For dry nasal membranes

Question:

emipregrp@gmail.com

See Label

3 PERCENT SALINE SOLUTION 
sodium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85602-102
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85602-102-02	30 in 1 BOX	04/30/2025
1	NDC: 85602-102-01	5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/30/2025	12/31/2025

Labeler - EMPIRE GROUPS LLC (126061466)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Jinsheng Biotechnology Corporation		402822781	manufacture(85602-102)

Revised: 12/2025

Document Id: 4713179d-f668-b2c5-e063-6294a90a79dd

34390-5

Set id: 33f9a755-a7bc-5e24-e063-6394a90a94de

Version: 2

Effective Time: 20251229