MedPath

Horse Health

Ivermectin Paste

Approved
Approval ID

54eb41d1-e3c0-45fc-a563-bc1d07e02307

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

Farnam Companies, Inc.

DUNS: 008399933

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ivermectin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17135-710
Application NumberANADA200390
Product Classification
M
Marketing Category
C73583
G
Generic Name
Ivermectin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (1)

IvermectinActive
Quantity: 1.87 g in 100 g
Code: 8883YP2R6D
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2025

Horse Health - Container Label - 6.08g

Horse Health - Single Unit Carton - 6.08g

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/2/2025

Approved by FDA under ANADA # 200-390 NDC 17135-710-21

HORSE HEALTH (ivermectin paste) 1.87%
Anthelmintic and Boticide
For Oral Use in Horses Only

Contents will treat up to 1250 lb body weight.
Removes worms and bots with a single dose.

Each Syringe Contains 0.21 oz (6.08 g) HORSE HEALTH (ivermectin paste) 1.87%

**INDICATIONS:**Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Horse Health (ivermectin paste) 1.87% provides effective treatment and control of the following parasites in horses.

Large Strongyles (adults) – Strongylus vulgaris (also early forms in blood vessels), S.edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T.serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds) – Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum;Small Strongyles – Fourth-stage larvae;Pinworms (adults and fourth-stage larvae) – Oxyuris equi;Ascarids (adults and third- and fourth-stage larvae) – Parascaris equorum;Hairworms (adults) – Trichostrongylus axei;Large-mouth Stomach Worms (adults) – Habronema muscae;Bots (oral and gastric stages) – Gasterophilus spp. including G. intestinalis and G. nasalis;Lungworms (adults and fourth-stage larvae) – Dictyocaulus arnfieldi;Intestinal Threadworms (adults) – Strongyloides westeri;Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/2/2025

DOSAGE:

This syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb body weight.

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:

(1) While holding plunger, turn the knurled ring on the plunger to the right to move it up towards the barrel until the side nearest the barrel aligns with the line at the prescribed weight marking, as shown in the pictogram.

(2) Ensure the ring is secured at the appropriate weight by turning the ring 1/4 turn to the left.

(3) Make sure that the horse’s mouth contains no feed.

(4) Remove the cover from the tip of the syringe.

(5) Insert the syringe tip into the horse’s mouth at the space between the teeth.

(6) Depress the plunger as far as it will go, depositing paste on the back of the tongue.

(7) Immediately raise the horse’s head for a few seconds after dosing.

![Ivermectin 6.08 Syringe - Handle Close-up - 2 rotated](/dailymed/image.cfm?name=Ivermectin+6.08+Syringe+-+Handle+Close- up+-+2+rotated.jpg&id=895808)

PARASITE CONTROL PROGRAM: All horses should be included in a regular parasite control program with particular attention being paid to mares, foals and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. Consult your
veterinarian for a control program to meet your specific needs. Horse HealthTM (ivermectin paste) 1.87% effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.

**PRODUCT ADVANTAGES:**Broad-spectrum Control– Horse HealthTM (ivermectin paste) 1.87% kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. Horse HealthTM (ivermectin paste) 1.87% is a potent antiparasitic agent that is
neither a benzimidazole nor an organophosphate.

ANIMAL SAFETY: Horse HealthTM (ivermectin paste) 1.87% may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/28/2025

WARNING: Do not use in horses intended for human consumption.
Not for use in humans. Keep this and all drugs out of reach of children.

Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain an SDS, contact Farnam Companies, Inc. at 800-234-2269.

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 8/28/2025

PRECAUTIONS: Horse HealthTM (ivermectin paste) 1.87% has been formulated specifically for use in horsesONLY. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

OTHER WARNINGS: 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, 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 WARNING SECTION

LOINC: 50742-6Updated: 8/28/2025

**Environmental Safety:**Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.

INFORMATION FOR OWNERS/CAREGIVERS SECTION

LOINC: 50744-2Updated: 8/28/2025

INFORMATION FOR HORSE OWNERS:

Swelling and itching reactions after treatment with Horse HealthTM (ivermectin paste) 1.87% have occurred in horses carrying heavy infections of neck threadworm (Onchocerca sp.) microfilariae. These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with Horse HealthTM (ivermectin paste) 1.87%. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/2/2025

CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Farnam Companies, Inc. at 800-234-2269. For additional information about adverse drug experience reporting for animal drugs, contact FDA at

1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae

STORAGE INFORMATION: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C - 30°C (between 59°F and 86°F).

©2010-2023 Farnam Companies, Inc. RM: 99.0000276.05 • HH022023-3 Horse Health is a trademark of Farnam Companies, Inc.

Rev. 10/23

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Horse Health - FDA Drug Approval Details