Sterile Water for Inhalation

Sterile Water for INHALATION by

Drug Labeling and Warnings

Sterile Water for INHALATION by is a Prescription medication manufactured, distributed, or labeled by SENSIMEDICAL LLC, Laboratorios Biogalenic. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STERILE WATER FOR INHALATION- sterile water for inhalation inhalant 
SENSIMEDICAL 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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Sterile Water for Inhalation

Medicinal Ingredient: Water 1 g/mL

NON PYROGENIC

pH 5

FOR INHALATION THERAPY ONLY

NOT FOR PARENTAREL ADMINISTRATION

Recommended Storage: Room temperature (25°C/77°F)

Avoid Excessive Heat.  Protect from freezing.

Manufactured For:

SENSIMEDICAL LLC

19495 Biscayne Blvd PH2

Aventura, Florida 33180

Made in El Salvador

STERILE WATER FOR INHALATION 
sterile water for inhalation inhalant

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 78718-000
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	1 g  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78718-000-01	500 mL in 1 BAG; Type 0: Not a Combination Product	04/30/2021	02/16/2022
2	NDC: 78718-000-00	1000 mL in 1 BAG; Type 0: Not a Combination Product	04/30/2021	02/16/2022
3	NDC: 78718-000-02	2000 mL in 1 BAG; Type 0: Not a Combination Product	04/30/2021	02/16/2022
4	NDC: 78718-000-21	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2021	02/16/2022
5	NDC: 78718-000-23	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2021	02/16/2022
6	NDC: 78718-000-25	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2021	02/16/2022
7	NDC: 78718-000-27	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/03/2021	02/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/30/2021	02/16/2022

Labeler - SENSIMEDICAL LLC (117526048)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Biogalenic		851259507	manufacture(78718-000) , api manufacture(78718-000)

Revised: 2/2022

Document Id: a3d0e6c8-2b71-4453-a6b6-1665be77ab11

34391-3

Set id: a2685f47-7f67-47b2-b4c1-6de587b768a7

Version: 4

Effective Time: 20220216