Durvet IVERMECTIN POUR-ON (ivermectin topical solution) for Cattle

Manufacturer
Durvet, Inc. | Norbrook Laboratories Limited
Effective date
2020-11-06
Label type
OTC ANIMAL DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:40:49

Label at a glance#

ProductIvermectin Pour-On for Cattle
Active ingredientivermectin
Label structure15 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Contains 5 mg ivermectin/mL

Parasiticide

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

INTRODUCTION

SPL UNCLASSIFIED SECTION

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

MODE OF ACTION

SPL UNCLASSIFIED 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 macrocylic 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

Ivermectin Pour-On (ivermectin topical solution) applied at the recommended dose level of 500 mcg/kg is indicated for the effective control of these parasites.

Gastrointestinal Roundworms

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.
Lungworms
(adults)
Dictyocaulus viviparus(adults and L4)
Cattle Grubs
Hypoderma bovis
H. lineatum
(parasitic stages)

Mites

Sarcoptes scabiei var. bovis

Lice

Linognathus vituli

Haematopinus eurysternus

Damalinia bovis

Solenopotes capillatus

Horn Flies

Haematobia irritans

PERSISTENT ACTIVITY

SPL UNCLASSIFIED SECTION

Ivermectin Pour-On (ivermectin topical solution) has been proved to effectively control infections and to protect cattle from re-infection with: Oesophagostomum radiatum and Dictyocaulus viviparus 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

SPL UNCLASSIFIED SECTION

Ivermectin Pour-On (ivermectin topical solution) controls horn flies (Haematobia irritans) for up to 28 days after dosing. For best results Ivermectin Pour-On 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 FORMS & STRENGTHS 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.

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.

ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Metering Cup with Measure-Squeeze-Pour System

SPL UNCLASSIFIED SECTION

(1 Liter (33.8 fl oz) Container with 25 mL Metering Cup)

This pack contains 1 Metering Cup and 1 dip tube

  1. Insert the dip tube into base of the Metering Cup. Leave the “slotted end” of the dip tube exposed in the bottom of the container.
  2. Unscrew shipping cap from container top.
  3. Screw the Metering Cup onto container top
  4. Measure: To select the correct dose rate, rotate the adjuster cap (top) in either direction to position the dose indicator to the weight of the animal you want to treat. When body weight is between markings, use the higher setting.
  5. Squeeze the container gently to fill the Metering Cup to the required dose. Release your grip and any excess will return to the container.
  6. Pour: Apply the full dose by tipping and pouring along the backline of the animal until the Metering Cup is empty.
  7. Storage: The Metering Cup should not remain attached to the container when not in use. Detach the Metering Cup after each use and replace the shipping cap to close the container top.

Collapsible Pack (84.5 fl oz/2.5 L Pack and 169 fl oz/5 L Pack)

SPL UNCLASSIFIED SECTION

Connect the applicator gun to the collapsible pack as follows:

  • Attach the open end of the draw-off tubing to the dosing equipment. (Because of the solvents used in the formulation, only the Simcro Tech gun, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage.)
  • Replace the shipping cap with the draw-off cap and tighten down. Attach draw-off tubing to the draw-off cap.
  • Gently prime the applicator gun, checking for leaks.
  • Follow the manufacturer's directions for adjusting the dose
  • When the interval between uses of the applicator gun is expected to exceed 12 hours, disconnect the gun and draw-off tubing from the product container and empty the product from the gun and tubing back into the product container. To prevent removal of special lubricants from the Simcro Tech gun, the gun and tubing must not be washed.

20 Liter Pack (676 fl oz/20 L Pack)

SPL UNCLASSIFIED SECTION

Use dosing equipment (applicator, draw-off tubing, cap with stem) compatible with Ivermectin Pour-On (ivermectin topical solution). Other dosing equipment may be incompatible, resulting in locking, incorrect dosage and leakage. Follow the dosing equipment manufacturer's directions for adjusting the dose and proper use and maintenance of the dosing equipment. Connect the dosing applicator and the draw-off tubing to the container as follows:

  • Attach the open end of the draw-off tubing to an appropriate dosing applicator. Attach draw-off tubing to the cap with the stem. Replace the shipping cap with the cap having the draw-off tubing. Gently prime the dosing applicator, checking for leaks.
  • When the interval between uses of the applicator gun is expected to exceed 12 hours, disconnect the gun, draw-off tubing and cap with stem from the product container, empty the product from the gun and tubing back into the product container and replace the shipping cap.
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

ANIMAL SAFETY

ANIMAL PHARMACOLOGY & OR TOXICOLOGY 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.

WARNING

WARNINGS SECTION

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 suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Norbrook at 1-866-591-5777. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

WARNING! FLAMMABLE!

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

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.

SPL UNCLASSIFIED SECTION

RESIDUE WARNING: 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.

PRECAUTIONS

PRECAUTIONS SECTION

  • Store at or below 25°C (77°F), excursions permitted up to 40°C (104°F). Protect from light.
  • 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 Ivermectin Pour-On is stored at temperatures below 32° F. Allowing it 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 dermatoses or adherent materials, e.g. caked mud or manure.
  • Ivermectin has been associated with adverse reactions in sensitive dogs; therefore, Ivermectin Pour-On (ivermectin topical solution) is not recommended for use in species other than cattle.

When to Treat Cattle with Grubs

SPL UNCLASSIFIED SECTION

Ivermectin Pour-On 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 Ivermectin Pour-On at the end of the fly season may be re-treated with Ivermectin during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian.

OTHER WARNINGS

SPL UNCLASSIFIED 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 treatment 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 reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

Environmental Safety

SPL UNCLASSIFIED 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 or 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

Ivermectin Pour-On (ivermectin topical solution) is available in a 33.8 fl oz/1L bottle with a measure-squeeze-pour-system or in an 84.5 fl oz/2.5 L or 169 oz/5 L collapsible pack, or 676 fl oz/20 L container intended for use with appropriate automatic dosing equipment.

Restricted Drug - California. Use Only as Directed.

Approved by FDA under ANADA # 200-272

Manufactured for:
DURVET, INC.
Blue Springs, Missouri 64014

www.durvet.com

Rev. 03/20 009215I04

Principal Display Panel - 5 L Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

durvet

IVERMECTIN POUR-ON

(ivermectin topical solution)
for Cattle

Contains 5 mg ivermectin/mL

Parasiticide

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

Contains 200 - 550 lb doses

Approved by FDA under ANADA # 200-272

169 fl oz (5 L)

Principal Display Panel - 5 L Carton Label
Principal Display Panel - 5 L Carton Label

Principal Display Panel - 5 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

durvet

IVERMECTIN POUR-ON

(ivermectin topical solution)
for Cattle

Contains 5 mg ivermectin/mL

Parasiticide

Kills:

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

Manufactured for:

DURVET, INC.

Blue Springs, Missouri 64014

www.durvet.com

Approved by FDA under ANADA # 200-272

169 fl oz (5 L)

Principal Display Panel - 5 L Bottle Label
Principal Display Panel - 5 L Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978030ivermectin 5 MG/ML Topical SolutionPSN5
978030ivermectin 5 MG/ML Topical SolutionSCD5

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
30798-240-19Ivermectin Pour-On for Cattle5000 mL in 1 CONTAINERSOLUTION50005
30798-240-19Ivermectin Pour-On for Cattle1 in 1 CARTONSOLUTION15
30798-240-20Ivermectin Pour-On for Cattle1 in 1 CARTONSOLUTION15
30798-240-20Ivermectin Pour-On for Cattle1000 mL in 1 CONTAINERSOLUTION10005
30798-240-78Ivermectin Pour-On for Cattle2500 mL in 1 CONTAINERSOLUTION25005
30798-240-78Ivermectin Pour-On for Cattle1 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30798-240IVERMECTIN POUR-ON FOR CATTLE (IVERMECTIN) SOLUTION [DURVET, INC.]56 package rows20201110_f5aa53ab-2c44-4652-88fc-11bde79dce8d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ivermectinACTIVE INGREDIENT8883YP2R6D3
ivermectinACTIVE MOIETY8883YP2R6D3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD3
isopropyl alcoholINACTIVE INGREDIENTND2M4163023
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJS3
trolamineINACTIVE INGREDIENT9O3K93S3TK3

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30798-24030798-240-20, 30798-240-78, 30798-240-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 86 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii candidate
18 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii candidate
37 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TRANSDERMAL113 mgExact identifier — unii candidate
18 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSFILM, EXTENDED RELEASE / TRANSDERMAL20.4 mgExact identifier — unii candidate
18 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii candidate
37 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii candidate
37 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSGEL / TRANSDERMAL85 mgExact identifier — unii candidate
18 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL / TOPICAL9.3 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TOPICAL7 mgExact identifier — unii candidate
18 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDMOUTHWASH / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSCREAM / VAGINAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSOIL / AURICULAR (OTIC)36 mgExact identifier — unii candidate
18 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
18 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates

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 · 35 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
lice treatment dedicatedIVERMECTINShenzhen Zhenshangzekai Technology Co., Ltd.459879fb-efd1-9fc1-e063-6394a90a98b02025-12-10WarningsName fallback
generic name: IVERMECTIN
ivometn ivermectin lice treatmentIVERMECTINShenzhen Zhenshangzekai Technology Co., Ltd.459b4316-89df-0bb1-e063-6294a90a518d2025-12-10WarningsName 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

Reported adverse events (FAERS/openFDA)#

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