FDA.reportPublic FDA data

ANTISEPSIS BOLUS

Manufacturer
Sparhawk Laboratories, Inc.
Effective date
2014-04-28
Label type
OTC ANIMAL DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:39:45

Label at a glance#

ProductANTISEPSIS BOLUS
Active ingredientUREA
Label structure6 sections

Dosage and administration

For intrauterine or topical use only. Insert boluses into uterus or dissolve in 1 pint warm water to make a flush. Cattle: 2-4 boluses Sheep: 1/2-1 bolus For topical application, dissolve 4 boluses in one pint of warm water and thoroughly flush wound. Repeat treatment in 24 to 48 hours if necessary.

Storage and handling

Store in a cool dry place;  Keep container tightly closed when not in use .; TAKE TIME OBSERVE LABEL DIRECTIONS

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

ANTISEPTIC AND PROTEOLYTIC BOLUS

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

INDICATIONS

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

PRECAUTION

PRECAUTIONS SECTION

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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

For intrauterine or topical use only. Insert boluses into uterus or dissolve in 1 pint warm water to make a flush.
Cattle: 2-4 boluses
Sheep: 1/2-1 bolus
For topical application, dissolve 4 boluses in one pint of warm water and thoroughly flush wound.
Repeat treatment in 24 to 48 hours if necessary.

COMPOSITION

COMPONENTS

Each bolus contains: Urea, 13.4  g

STORAGE AND HANDLING SECTION

Store in a cool dry place; Keep container tightly closed when not in use.; TAKE TIME OBSERVE LABEL DIRECTIONS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SLI Antisepsis Bolus 14SLI Antisepsis Bolus 14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58005-762-02ANTISEPSIS BOLUS50 in 1 JARTABLET505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58005-762ANTISEPSIS BOLUS (UREA) TABLET [SPARHAWK LABORATORIES, INC.]51 package rows20140428_6318f8ef-2870-4d58-a307-558dafd43967.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
UREAACTIVE INGREDIENT8W8T17847W5
UREAACTIVE MOIETY8W8T17847W5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58005-76258005-762-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
UREA8W8T17847WACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UREDEXUREABlue Heron Pharmaceuticals, LLC0e4d7b03-527f-4cff-9154-7e5e485a8f802026-07-13Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40UREAKrewe Pharma, LLC415c4efd-95bd-4276-900c-e9da70266cd42026-06-02WarningsName fallback
generic name: UREA
Urea 39UREAKrewe Pharma, LLCbe19358f-67a8-4a0d-88e0-91eb4cb42e0d2026-06-02WarningsName fallback
generic name: UREA
UREVEXUREABlue Heron Pharmaceuticals, LLC1ed71529-7607-47ff-bd16-3c9a63e1c7332026-04-28Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40 PercentUREABryant Ranch Prepack6701225c-2c2e-41e8-8d43-ef77c00a99462026-04-24Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40 PercentUREABryant Ranch Prepackee06a590-a104-4e97-b66c-cd37869038a52026-03-27Warnings, Adverse reactionsName fallback
generic name: UREA
Urea Cream 40 PercentUREABryant Ranch Prepacke28969bc-c3a0-49e5-9947-aee0c6b8b0b52026-02-13Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40 PercentUREAMethod Pharmaceuticals, LLCd35b75e1-937d-ebc4-e053-2a95a90ac0d82026-02-12Warnings, Adverse reactionsName fallback
generic name: UREA
Urea Cream 40 PercentUREAMethod Pharmaceuticals, LLC0920f780-b504-1fea-e063-6394a90ae5a92026-01-15Warnings, Adverse reactionsName fallback
generic name: UREA
UREAUREABioComp Pharma, Inc.0fb373f8-5328-2f10-e063-6294a90a24842026-01-13Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 20UREAAvPAKe994fa05-a457-2555-e053-2a95a90ae83b2026-01-12WarningsName fallback
generic name: UREA
UREAUREABioComp Pharma, Inc.6774a5ef-9bb0-4e7a-e053-2a91aa0af47f2025-12-17Warnings, Adverse reactionsName fallback
generic name: UREA
Urea Cream 40 PercentUREABryant Ranch Prepack59afcfbe-fe04-49c9-b1c5-28f2c4311c012025-11-12Warnings, Adverse reactionsName fallback
generic name: UREA
Urea Cream 40%UREALaser Pharmaceuticals, LLCef2db58d-e760-417d-8574-45a411c49b472025-11-06Warnings, Adverse reactionsName fallback
generic name: UREA
Urea Cream 41%UREALaser Pharmaceuticals, LLCada4d313-1050-4501-9c93-68dfb3a2c9e42025-11-06Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40 PercentUREABryant Ranch Prepack3d9bf300-cb72-463b-be9a-70c8d9a55b632025-10-29Warnings, Adverse reactionsName fallback
generic name: UREA
UREAUREACintex Services, LLC4137c430-bd2b-07a1-e063-6394a90afed92025-10-15Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40%UREAPatrin Pharma, Inc53ccf801-c1c6-42c8-a511-da33c308076f2025-08-21Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 41%UREAOncora Pharma, LLC37576876-738c-ac79-e063-6394a90a84fe2025-06-11Warnings, Adverse reactionsName fallback
generic name: UREA
UREAUREABantry Pharma, LLCcb6ddbfc-ea6a-0ddc-e053-2995a90aedc42025-06-04Warnings, Adverse reactionsName fallback
generic name: UREA

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.