Sterile Water by Nova-Tech, Inc. STERILE WATER injection

Sterile Water by

Drug Labeling and Warnings

Sterile Water by is a Animal medication manufactured, distributed, or labeled by Nova-Tech, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CAUTION:

Do not use this product if seal is broken or solution is not clear. Contains no preservative. If entire contents are not used, discard unused portion. Additives may be incompatible. When introducing additives, use aseptic technique, mix thoroughly, and do not store.

CONTAINS:

Water For Injection, USP.................100%

This is a single dose vial. After a quantity has been withdrawn for use the remainder should be discarded.

GENERAL PRECAUTIONS

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS

Manufactured by:

Nova-Tech, Inc.

Grand Island, NE 68801 USA

18-808

RMS 92-356

Assembled in USA

Lot No.

Exp. Date

GENERAL PRECAUTIONS

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

INDICATIONS & USAGE

This sterile water for injection is made by reverse osmosis and is suitable for use as a diluent for preparation of pharmaceutical solutions when made isotonic by addition of suitable solutes. This product contains no preservatives; solutions made from this water should be used promptly.

STORAGE AND HANDLING

Store between 15°C - 30°C (59°F - 86°F)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STERILE WATER 
sterile water injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 65207-808
Route of Administration	PARENTERAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	1000 mL  in 1000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65207-808-60	1000 mL in 1 BOTTLE, PLASTIC
2	NDC: 65207-808-50	500 mL in 1 BOTTLE, PLASTIC
3	NDC: 65207-808-25	250 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/21/2019

Labeler - Nova-Tech, Inc. (196078976)

Registrant - Nova-Tech, Inc. (196078976)

Establishment
Name	Address	ID/FEI	Business Operations
Nova-Tech, Inc.		196078976	manufacture, api manufacture