Sterile Water

STERILE WATER — water injection, solution
REMEDYREPACK INC.

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.

SPL UNCLASSIFIED

Rx Only

BOXED WARNING

NOT FOR DIRECT INJECTION

DESCRIPTION

Sterile Water for Injection, USP is water for injection sterilized and packaged in single dose vials. It contains no antimicrobial agents or other preservatives. It is used as a diluent. Non-pyrogenic.

PRECAUTIONS

Unused amount should be discarded immediately following withdrawal of any portion of vial contents. Sterile Water for Injection is not isotonic and should not be injected directly into the body.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

HOW SUPPLIED

Sterile Water for Injection, USP

NDC 0517-3005-25 5 mL Single Dose Vial Packaged in 25
NDC 0517-3010-25 10 mL Single Dose Vial Packaged in 25
NDC 0517-3020-25 20 mL Single Dose Vial Packaged in 25
NDC 0517-3050-25 50 mL Single Dose Vial Packaged in 25

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN3005
Rev. 1/09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Sterile Water

GENERIC: Water

DOSAGE: INJECTION, SOLUTION

ADMINSTRATION: INTRAVENOUS

NDC: 61786-349-03

ACTIVE INGREDIENT(S):

  • WATER 1mL in 1mL

PACKAGING: 20 mL in 1 VIAL, SINGLE-DOSE

MM1
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MM2
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MM3
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STERILE WATER
water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-349(NDC:0517-3020)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61786-349-03 20 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/18/2015
Labeler — REMEDYREPACK INC. (829572556)

Revised: 06/2015 REMEDYREPACK INC.

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