Animal NDC 11695-6403-5 Sterile Water

Animal Product Information

Field Name Field Value
Animal NDC Code 11695-6403-5
Proprietary Name Sterile Water What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Sterile Water What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Covetrus
Product Type Prescription Animal Drug
Usage Information
    This sterile water for injection is made by reverse osmosis and deionization 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 preservative; solutions made from this water should be used promptly or sterilized with adequate precautions for maintaining sterility.
Active Ingredient(s)
  • Water
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Sterile Water Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.

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


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 After a quantity has been withdrawn for use the remainder should be discarded.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

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN


Indications:



This sterile water for injection is made by
reverse osmosis and deionization 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 preservative;
solutions made from this water should be used
promptly or sterilized with adequate precautions for
maintaining sterility.


Storage And Handling



Store between 15 degrees C and 30 degrees C (59 degrees F and 86 degrees F).


Information For Owners/Caregivers



18-808

RMS 92-526

NDC: 11695-6403-2

Sterile - nonpyrogenic

Volume: 8.454 fl oz (250 mL)

Questions? (855) 724-3461

Reorder #069172

Distributed by:
Covetrus North America

400 Metro Place North
Dublin, OH 43017

covetrus.com

Manufactured by
Nova-Tech, Inc.
Grand Island, NE 68801

Lot No.              

Exp. Date

Assembled in USA

AH-069172-01

REV: 0719 


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.