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Sterile Water for Inhalation Prescribing Information

Package insert / product label
Dosage form: inhalation solution
Drug class: Sterile irrigating solutions

Medically reviewed by Drugs.com. Last updated on Nov 28, 2023.

On This Page

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

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STERILE WATER FOR INHALATION
sterile water for inhalation inhalant
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:78718-000
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1 g in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78718-000-01500 mL in 1 BAG; Type 0: Not a Combination Product04/30/2021
2NDC:78718-000-001000 mL in 1 BAG; Type 0: Not a Combination Product04/30/2021
3NDC:78718-000-022000 mL in 1 BAG; Type 0: Not a Combination Product04/30/2021
4NDC:78718-000-21250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2021
5NDC:78718-000-23500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2021
6NDC:78718-000-251000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2021
7NDC:78718-000-272000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/30/2021
Labeler - SENSIMEDICAL LLC (117526048)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Biogalenic851259507manufacture(78718-000) , api manufacture(78718-000)

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