What are the FDA‑approved product labels and dosing tables for each marketed ivermectin formulation in the U.S.?

1. Human oral tablets: label indications, strengths and dosing framework

The approved human oral ivermectin tablets (marketed as STROMECTOL and generics) are available in 3 mg and 6 mg strengths and are indicated for intestinal strongyloidiasis and onchocerciasis, with efficacy demonstrated following single doses designed to provide approximately 200 micrograms per kilogram of body weight; the product labeling explicitly refers prescribers to a dosing table (Table 1) intended to achieve ~200 mcg/kg and states tablets should be taken on an empty stomach with water ^{[1] [7] [2]}. Clinical trials cited in the labels report cure rates after single 170–200 mcg/kg doses and pharmacokinetic data showing dose‑proportional plasma concentrations after oral dosing ^{[2] [1]}.

2. What the tablet dosing tables do — and what they do not state in the public snippets

The official tablet labels include a weight‑based dosing table to translate body weight into the number of 3 mg or 6 mg tablets needed to approximate a 200 mcg/kg single dose, and the labels state that, in general, additional doses are unnecessary though follow‑up stool exams are recommended to verify eradication ^{[1] [7]}. The publicly available excerpts confirm the existence and purpose of these dosing tables but the provided snippets do not reproduce the exact per‑weight tablet counts, so precise tablet‑count dosing rows from Table 1 cannot be quoted here without consulting the full label document ^[1].

3. Topical human formulation: Soolantra (ivermectin) cream, 1%

Soolantra cream (ivermectin 1%) is an FDA‑approved topical formulation for dermatologic use (rosacea); the approval package and label describe the product as 1% ivermectin cream with demonstrated efficacy by Week 12 in controlled trials and include pharmacokinetic and safety information specific to topical dosing ^{[3] [8]}. The label materials and FDA approval letter establish the cream’s marketed indication and clinical data, but the supplied snippets do not include the full application of dosing frequency or exact application instructions from the label in this excerpt, so those specifics should be read directly from the FDA label for prescribing guidance ^{[3] [8]}.

4. Veterinary ivermectin products and their labeled dosing

Veterinary ivermectin products marketed in the U.S. come in many forms—pour‑on topical solutions, injectables, drench liquids, pastes and more—and their labels contain species‑ and weight‑specific dosing; for example, an FDA‑listed pour‑on ivermectin solution for cattle contains 5 mg/mL and specifies a dose rate equating to 1 mL per 22 lb of body weight ^[4]. The FDA maintains separate approval pathways and labeling for animal products (ANADA/NADA), and the animal labels and human labels are not interchangeable; the FDA explicitly warns that animal products are different from human products and are safe only as labeled for animals ^{[5] [4]}.

5. Context, limits of the reviewed labels, and off‑label controversies

Regulatory and clinical guidance stresses the approved human uses and dosing tables while explicitly rejecting ivermectin for COVID‑19, noting that antiviral in‑vitro concentrations exceed what is achievable with approved human doses and that public health agencies recommend against use for COVID‑19 outside clinical trials ^{[5] [6]}. The documents reviewed here confirm the existence of dosing tables and label‑specific instructions for each marketed formulation, but the provided excerpts do not reproduce the full numeric dosing tables for human tablets or the cream application directions; accessing the full SPL/label PDFs on FDA/DailyMed is necessary to obtain the exact per‑weight tablet counts and step‑by‑step topical dosing instructions for clinical use ^{[1] [3]}.