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Ivermectin

Ivermectin Horse Paste 1.87

Approved
Approval ID

347e3018-cb70-4104-961a-f9159c41cecc

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Fast Sold LLC

DUNS: 123898597

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 Code86241-001
Application NumberANADA200326
Product Classification
M
Marketing Category
C73583
G
Generic Name
Ivermectin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (1)

IVERMECTINActive
Quantity: 18.7 mg in 1 g
Code: 8883YP2R6D
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

PRINCIPAL DISPLAY PANEL - 0.21 oz (6.08g)

Keep out of reach of children

For Oral Use in Horses Only

NDC: 86241-001-01

IVERMECTIN
(ivermectin paste) 1.87%

Net Wt. 0.21 oz (6.08)
Contents will treat up to 1250 lb body weight

Approved by FDA under # 200-326

Apple Flavored

![ivemectin-final-lable-02.jpg](/dailymed/image.cfm?name=ivemectin-final- lable00.jpg&id=892229)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/4/2025

INDICATIONS: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. IVERMECTIN (ivermectin paste) 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)-Trichostrogylus 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.

DESCRIPTION SECTION

LOINC: 34089-3Updated: 8/12/2025

For Oral Use in Horses Only

IVERMECTIN
(ivermectin paste) 1.87%

Net Wt. 0.21 oz (6.08)
Contents will treat up to 1250 lb body weight

Approved by FDA under # 200-326

Apple Flavored

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/6/2025

ADMINISTRATION:

(1) While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking, aligning the arrow on the ring to the line between the weight and lbs, as shown in the pictogram.
(2) Lock the ring in place by making a 1/4 turn to the right. Ensure it is locked (it should no longer slide).
(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.

plunger

WARNINGS SECTION

LOINC: 34071-1Updated: 8/4/2025

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 suspected adverse drug events, for technical assistance, or to obtain a copy of the SDS contact Durvet, Inc. at 1-800-821-5570. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/6/2025

STORAGE INFORMATION: Store at 68°F - 77°F (20°C - 25°C). Excursions between 59°F - 86°F (15°C - 30°C) are permitted.

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 8/4/2025

PRECAUTIONS: IVERMECTIN (ivermectin paste) has been formulated specifically for use in horses only. 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 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 HORSE OWNERS: Swelling and itching reactions after treatment with IVERMECTIN (ivermectin paste) 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 IVERMECTIN. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/6/2025

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Ivermectin - FDA Drug Approval Details