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.

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STERILE WATER FOR INJECTION, USP(pH 5.0-7.0)

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

MM2

MM3

STERILE WATER 
water injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61786-349(NDC:0517-3020)
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-349-0320 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product06/19/201506/19/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/19/201506/19/2016
Labeler - REMEDYREPACK INC. (829572556)

Revised: 8/2017
 
REMEDYREPACK INC.