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Sterile Water for Inhalation

Package insert / prescribing information
Dosage form: inhalation solution
Drug class: Sterile irrigating solutions

Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.

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

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 LABEL Item Code (Source) NDC:78718-000
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 g in 1 mL
Packaging
# Item Code Package Description
1 NDC:78718-000-01 500 mL in 1 BAG
2 NDC:78718-000-00 1000 mL in 1 BAG
3 NDC:78718-000-02 2000 mL in 1 BAG
4 NDC:78718-000-21 250 mL in 1 BOTTLE, PLASTIC
5 NDC:78718-000-23 500 mL in 1 BOTTLE, PLASTIC
6 NDC:78718-000-25 1000 mL in 1 BOTTLE, PLASTIC
7 NDC:78718-000-27 2000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/30/2021
Labeler - SENSIMEDICAL LLC (117526048)
Establishment
Name Address ID/FEI Operations
Laboratorios Biogalenic 851259507 manufacture(78718-000), api manufacture(78718-000)
SENSIMEDICAL LLC