Vetrimec™ Pour-On (ivermectin topical solution) for Cattle

Manufacturer
VetOne | First Priority Incorporated
Effective date
2023-10-12
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:42:22

Label at a glance#

ProductVetrimec POUR-ON
Active ingredientIVERMECTIN
Label structure22 sections

Label contents#

Full prescribing information#

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Approved by FDA under ANADA # 200-340
Contains 5 mg ivermectin/mL

PARASITICIDE
Kills: Roundworms (including Brown Stomach Worm), Lungworms, Grubs, Sucking Lice, Biting Lice, Mange Mites, Horn Flies

ENVIRONMENTAL WARNING SECTION

image of environmental warningimage of environmental warning

PRECAUTIONS SECTION

WARNING! FLAMMABLE!
KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME, AND OTHER SOURCES OF IGNITION.

Restricted Drug (California) - Use Only as Directed
For Animal Use Only • Keep Out of Reach of Children

Parasiticide

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

INTRODUCTION

VETERINARY INDICATIONS SECTION

Vetrimec™ Pour-On for Cattle (ivermectin topical solution) delivers internal and external parasite control in one convenient low-volume application. Vetrimec™ Pour-On for Cattle contains ivermectin, a unique chemical entity.

MODE OF ACTION

PHARMACODYNAMICS SECTION

Ivermectin is a member of the macrocylic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells.
This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by
the neurotransmitter gamma-aminobutyric acid (GABA).
The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier

INDICATIONS

INDICATIONS & USAGE SECTION

Vetrimec™ Pour-On for Cattle applied at the recommended dose level of 500 mcg/kg is indicated for the effective treatment and control of these parasites.

Gastrointestinal Roundworms

INFORMATION FOR PATIENTS SECTION

Ostertagia ostertagi                                     (including inhibited stage) (adults and L4)
Haemonchus placei                                    
  (adults and L4)
Trichostrongylus axei                                
  (adults and L4)
T. colubriformis                                          
  (adults and L4)
Cooperia oncophora                                  
  (adults and L4)
Cooperia punctata                                       
(adults and L4)
Cooperia surnabada                                    
(adults and L4)
Strongyloides papillosus                             
  (adults)
Oesophagostomum radiatum                       
(adults and L4)
Trichuris spp.                                               
(adults)
Lungworms
Dictyocaulus viviparus                                
(adults and L4)
Cattle Grubs
 (parasitic stages)
Hypoderma bovis
H. lineatum
Mites
Sarcoptes scabiei var. Bovis
Lice
Linognathus vituli
Haematopinus eurystemus
Damalinia bovis
Solenopotes capillatus
Horn Flies
Haematobia irritans

PERSISTENT ACTIVITY

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

Vetrimec™ Pour-On for Cattle has been proved to effectively control infections and to protect cattle from re-infection with: Oesophagostomum radiatum and Dictyocaulus viviparous for 28 days after treatment; Cooperia punctata and Trichostrongylus axei for 21 days after treatment; Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora and Cooperia surnabada for 14 days after treatment; Damalinia bovis for 56 days after treatment.

TREATMENT OF CATTLE FOR HORN FLIES

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

Vetrimec™ Pour-On for Cattle controls horn flies (Haematobia irritans) for up to 28 days after dosing. For best results Vetrimec™ Pour-On for Cattle should be part of a parasite control program for both internal and external parasites based on the epidemiology of these parasites. Consult your veterinarian or an entomologist for the most effective timing of applications.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

The dose rate is 1 mL for each 22 lb of body weight. The formulation should be applied along the topline in a narrow strip extending from the withers to the tailhead.

ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

For the 250 mL and 1 Liter containers, see the diagram on the last page of this insert. Each 5 mL will treat 110 lbs body weight. When body weight requires a drug product volume that is between the measuring markings, use the next higher increment.

Applicator Gun

DOSAGE & ADMINISTRATION SECTION

(2.5 L, 5 L and 5 gallon bottles)
Because of the solvents used in Vetrimec™ Pour-On for Cattle, an applicator gun is recommended.
Follow the applicator gun manufacturer’s directions for priming the gun, adjusting the dose, and care of the applicator gun following use.

DOSAGE & ADMINISTRATION SECTION
Weight/Dose Chart
 Weight    Dose
220 lb (100 kg) 10 mL
330 lb (150 kg) 15 mL
 440 lb (200 kg) 20 mL
 550 lb (250 kg) 25 mL 
 660 lb (300 kg) 30 mL 
 770 lb (350 kg) 35 mL
 880 lb (400 kg) 40 mL
 990 lb (450 kg) 45 mL
 1100 lb (500 kg) 50 mL

Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment and encourage the development of parasite resistance.

ANIMAL SAFETY

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Studies conducted in the U.S.A. have demonstrated the safety margin for ivermectin. Based on plasma levels, the topically applied formulation is expected to be at least as well tolerated by breeding animals as is the subcutaneous formulation which had no effect on breeding performance.

WARNINGS AND PRECAUTIONS SECTION

WARNING! NOT FOR USE IN HUMANS
Keep this and all drugs out of the reach of children.
The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse effects, obtain an SDS or for assistance, contact First Priority, Inc. at 1-800-650-4899.
This product should not be applied to self or others because it may be irritating to human skin and eyes and absorbed through the skin. To minimize accidental skin contact, the user should wear a long-sleeved shirt and rubber gloves. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water and seek medical attention.
WARNING! FLAMMABLE! KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME, AND OTHER SOURCES OF IGNITION.

RESIDUE WARNING:

RESIDUE WARNING SECTION

Cattle must not be treated within 48 days of slaughter for human consumption. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

OTHER WARNINGS:

WARNINGS SECTION

  • Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.
  • Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance.
  • Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatments should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).
  • A decrease in a drug's effectiveness over time as calculated by fecal egg count reductions tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

PRECAUTIONS:

PRECAUTIONS SECTION

  • Store at or below 25°C (77°F) and protect from light. Excursions permitted to 104°F (40°C).
  • Use only in well-ventilated areas or outdoors.
  • Close container tightly when not in use.
  • Cattle should not be treated when hair or hide is wet since reduced efficacy may be experienced.
  • Do not use when rain is expected to wet cattle within six hours after treatment.
  • This product is for application to skin surface only. Do not give orally or parenterally.
  • Cloudiness in the formulation may occur when Vetrimec™ Pour-On for Cattle is stored at temperatures below 32°F. Allowing to warm at room temperature will restore the normal appearance without affecting efficacy.
  • Antiparasitic activity of ivermectin will be impaired if the formulation is applied to areas of the skin with mange scabs or lesions, or with dermatosis or adherent materials, e.g., caked mud or manure.
  • Ivermectin has been associated with adverse reactions in sensitive dogs; therefore, Vetrimec™ Pour-On for Cattle is not recommended for use in species other than cattle.
  • Restricted Drug (California) - Use Only as Directed.

When to Treat Cattle with Grubs

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

Vetrimec™ Pour-On for Cattle effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. While this is not peculiar to ivermectin, destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum when it is in the esophageal tissues may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either before or after these stages of grub development.
Cattle treated with Vetrimec™ Pour-On for Cattle at the end of the fly season may be re-treated with Vetrimec™ Pour-On for Cattle during the winter without danger of grub related reactions. For further information and advice on a planned parasite control program, consult your veterinarian.

Environmental Safety

ENVIRONMENTAL WARNING SECTION

Studies indicate that when ivermectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive over time.
Free ivermectin may adversely affect fish and certain aquatic organisms. Do not permit cattle to enter lakes, streams or ponds for at least six hours after treatment. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.
As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

HOW SUPPLIED:

HOW SUPPLIED SECTION

Vetrimec™ Pour-On for Cattle is available in 250 mL (8.5 fl oz) and 1 L (33.8 fl oz) tip and measure bottles, and 2.5 L (84.5 fl oz), 5 L (169.0 fl oz), and 5 Gallon (639.0 fl oz) containers for use with an appropriate automatic dosing applicator.

INFORMATION FOR OWNERS/CAREGIVERS SECTION

image of eye clockimage of eye clock

Distributed by: MWI
Boise, ID 83705
www.VetOne.net

Rev. 07/2023

DIAGRAM OF DEVICE

image of tip n measure deviceimage of tip n measure device

5 Liter (169.0 fl oz)V1 503002

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label onsert baseimage of label onsert baseimage of onsert labelimage of onsert labelimage of inner box labelimage of inner box labelimage of master case labelimage of master case label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978030ivermectin 5 MG/ML Topical SolutionPSN2
994507Vetrimec Pour-On 5 MG/ML Topical SolutionPSN2
994507ivermectin 5 MG/ML Topical Solution [Vetrimec]SBD2
978030ivermectin 5 MG/ML Topical SolutionSCD2
994507Vetrimec 5 MG/ML Topical SolutionSY2
994507Vetrimec Pour-On for Cattle 5 MG per 1 ML Topical SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IVERMECTIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7fd951fe-040a-0b64-2bea-eefc6aa4fc54Product name220250515
5b0ed980-56ce-7dd0-fb86-ff54be67c2e6Product name220200925
eed31638-1288-4eb6-a55c-5fc014dca98dProduct name320200728

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-990-05VetrimecPOUR-ON5 L in 1 JUGSOLUTION52
13985-990-05VetrimecPOUR-ON1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-990VETRIMEC POUR-ON (IVERMECTIN CATTLE POUR-ON) SOLUTION [VETONE]22 package rows20231013_cbdff895-692a-42dc-8e4e-4f6a396040a6.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13985-99013985-990-05

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
IVERMECTIN8883YP2R6DACTIB

Source Document#

Source XML

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 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvermectinIVERMECTINYYBA Corp59ea9767-2e0b-ebc2-e063-6294a90ab9042026-08-25WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINAzurity Pharmaceuticals, Inc.58c9cc4d-b1f3-1b6f-e063-6294a90ab5972026-08-11WarningsName fallback
generic name: IVERMECTIN
Head Lice Treatment Ivermectin Lotion118mLIVERMECTINYunqi Cosmetics (Shenzhen) Co., Ltd56a37d8f-c1b8-465a-e063-6394a90aa3342026-07-15WarningsName fallback
generic name: IVERMECTIN
SYNTHABIO IvermectinIVERMECTINShenzhen Xuyan Technology Co., Ltd.540d6a24-68bf-50c8-e063-6294a90aaa302026-06-22WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINAmerisourceBergen4e924212-cd7b-ccd9-e063-6394a90afb952026-04-16WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINAjanta Pharma USA Inc.1fb17bc2-9192-4a0b-a3ee-fda9db035daa2026-04-09Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINA-S Medication Solutions104a5045-94b1-4022-bc49-719521f30f0d2026-03-03Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINViona Pharmaceuticals Inc2de5ee45-0465-4996-ac00-5bdd352b4ed72026-02-27Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINZydus Lifesciences Limited6d626814-5288-441c-9508-f7f5130feceb2026-02-27Name fallback
generic name: IVERMECTIN
IvermectinIVERMECTINSun Pharmaceutical Industries, Inc.dd2c66e6-bd50-46df-a335-26215d02d13b2025-12-22WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINEdenbridge Pharmaceuticals LLC.847a1dd7-d65b-4a0e-a67d-d90392059dac2025-12-18Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINBryant Ranch Prepack1061e454-d1dc-4293-b18d-9c8717fbbb402025-10-23Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINCVS Pharmacy326e85c6-b95f-6aa8-e063-6294a90a49852025-06-20WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINActavis Pharma, Inc.de9253c3-7d66-47fe-8ad7-8c0d4ee8ebda2025-05-31Adverse reactionsName fallback
generic name: IVERMECTIN
RID One and DoneIVERMECTINOystershell Consumer Health, Inc.731a15f8-3578-4a95-b04c-aa6cf44a46652025-03-07WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINAdvagen Pharma Ltde88adfbc-e375-4fea-827e-6ec51ed6fd0a2025-01-29Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINWALMART INC.1608ec4a-2af4-4a43-a83f-5b25937068d12025-01-09WarningsName fallback
generic name: IVERMECTIN
IVERMECTINIVERMECTINDR. REDDY'S LABORATORIES, INC.4cb062d7-0597-4e92-b2f6-7129a95e95002024-11-19Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
SOOLANTRAIVERMECTINGalderma Laboratories, L.P.b1d5b166-ab06-4ab5-b0c6-31126238118a2024-10-24Adverse reactionsName fallback
generic name: IVERMECTIN
STROMECTOLIVERMECTINMerck Sharp & Dohme LLC681888c9-af79-4b7d-ae80-c3f4f6f1effd2024-09-20Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN

Reported adverse events (FAERS/openFDA)#

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