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Animal NDC 29983-2706-2 Clean-up

Urea

Animal Product Information

Field Name Field Value
Animal NDC Code 29983-2706-2
Proprietary Name Clean-up 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 Urea 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 Iba, Inc.
Product Type Otc Animal Drug
Usage Information
    ANTISEPTIC AND PROTEOLYTIC BOLUSFOR ANIMAL USE ONLYKEEP OUT OR REACH OF CHILDRENINDICATIONSFor use as an antiseptic and proteolytic aid in beef and dairy cattle and sheep.
Active Ingredient(s)
  • Urea
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.

Clean-up Images

Clean-up 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



Indications & Usage



ANTISEPTIC AND PROTEOLYTIC BOLUS

FOR ANIMAL USE ONLY

KEEP OUT OR REACH OF CHILDREN

INDICATIONS

For use as an antiseptic and proteolytic aid in beef and dairy cattle and sheep.


Precaution:



Do not administer orally.

Strict cleanliness must be observed to prevent introduction of further infections. Thoroughly cleanse hands and arms of operator and external genital parts of the animal with soap and water before inserting boluses or flush.

do not use in deep or puncture wounds or for serious burns.


Components



ACTIVE INGREDIENTS: Each Bolus contains:

Urea ..................... 13.4 g

INACTIVE INGREDIENTS: Microcrystalline Cellulose, DiTab, Sodium Starch Glycolate, Magnesium Stearate, Sipernat 22, Stearic Acid, FD&C Red #40 Lake.


Precautions



Do not administer orally. Strict cleanliness must be observed to prevent introduction of further infections. Thoroughly cleanse hands and arms of operator and external genital parts of the animal with soap and water before inserting boluses or flush. Do not use in deep wounds or for burns.


Storage



Keep container tightly closed when not in use. Store in a cool, dry place.


Dosage And Administration



For intrauterine or topical use only.

Insert boluses into uterus or dissolve in 1 pint warm water and make a flush.

Cattle: 2 - 4 boluses

Sheep: 1/2 - 1 bolus

For topical application, dissolve 4 boluses in one pint warm water and thoroughly flush wound.

Repeat treatment in 24 to 48 hours, if necessary.


Composition



Each bolus contains:

Urea ................................ 13.4 g


Storage And Handling



STORE IN COOL DRY PLACE

KEEP CONTAINER TIGHTLY CLOSED WHEN NOT IN USE

TAKE TIME OBSERVE LABEL DIRECTIONS


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