What are the FDA‑approved dosing labels for each specific human ivermectin product (by brand and indication)?
Executive summary
Two oral human ivermectin tablet products carry FDA-approved parasitic indications with weight‑based single‑dose regimens: marketed Stromectol/ivermectin tablets (designed to provide ~200 mcg/kg for strongyloidiasis and used in treatment of onchocerciasis in clinical studies) and an Ivermectin Tablets USP product with the same single‑dose recommendation; a separate FDA‑approved oral antiparasitic, moxidectin tablets, is labeled as a single 8 mg dose for onchocerciasis — beyond these, topical and other human ivermectin formulations are FDA‑approved for dermatologic and lice indications but the provided labels in the reporting do not fully expose dosing text for those products in this dataset [1] [2] [3] [4] [5].
1. Stromectol (ivermectin) tablets — parasitic indications and the 200 mcg/kg single dose
Stromectol (ivermectin) tablets are FDA‑labeled for treatment of intestinal (nondisseminated) strongyloidiasis due to Strongyloides stercoralis, and the label and supporting NDA documents state that the recommended regimen for strongyloidiasis is a single oral dose designed to provide approximately 200 micrograms of ivermectin per kilogram of body weight — a recommendation grounded in clinical trials showing cure rates after a single ~170–200 mcg/kg dose [6] [1] [2].
2. Stromectol and onchocerciasis — what the label and studies say about dosing
Onchocerciasis (river blindness) is another indication featured in Stromectol’s clinical record: controlled and open studies cited in the label document use single doses in the 150–200 mcg/kg range and report activity against microfilariae though not adult worms, and the label materials emphasize that ivermectin’s efficacy was shown in comparative trials versus other antiparasitics [1] [7].
3. Ivermectin Tablets USP (3 mg and 6 mg presentations) — equivalent dosing guidance
The Ivermectin Tablets USP product labeling (3 mg and 6 mg strengths) reiterates the same indication for intestinal strongyloidiasis and repeats the recommended dosing concept — a single oral dose designed to deliver approximately 200 mcg/kg — with clinical effectiveness defined by follow‑up stool examinations weeks after dosing [6] [2].
4. Moxidectin tablets — an FDA‑approved human alternative for onchocerciasis (single 8 mg dose)
Moxidectin, a related macrocyclic lactone distinct from ivermectin, is FDA‑labeled for treatment of onchocerciasis with a recommended regimen of a single 8 mg oral dose (four 2 mg tablets) taken once; the moxidectin label also notes limitations in data about repeat dosing and specific safety signals observed in trials [3].
5. Topical human ivermectin products and unlabeled dosing details in the provided reporting
The reporting references FDA labeling files for topical and dermatologic ivermectin products — Soolantra (ivermectin cream) is an FDA‑approved formulation for rosacea according to Medscape and an FDA label entry is listed — however the snippets provided here do not supply the explicit per‑application dosing instructions from the Soolantra label, so the precise wording of the approved topical dosing cannot be quoted from these sources alone [5] [4].
6. Important context, misuse, and limits of the dataset
Public controversy over ivermectin’s off‑label use for COVID‑19 is reflected in NIH/FDA guidance noting lack of efficacy at FDA‑approved doses and pharmacokinetic reasons why antiviral in vitro concentrations are not achievable at labeled human doses; that guidance underlines why the FDA‑approved labels remain focused on parasitic (and specific dermatologic) indications rather than viral disease [8]. The dataset includes FDA labels and clinical summaries for the tablet products and an moxidectin label but does not include full, extractable dosing text for every human topical product in the listing, and thus any precise per‑application phrasing for creams/lotions cannot be asserted here without consulting the live FDA labels [3] [4].
7. Takeaway and where to look next
For oral ivermectin in humans, the FDA‑approved tablet labels consistently specify a single‑dose, weight‑based regimen designed to deliver ~200 mcg/kg for strongyloidiasis and report use in onchocerciasis studies at similar dosing ranges [6] [1] [2]; moxidectin is an FDA‑approved single 8 mg oral dose for onchocerciasis [3]. For exact application instructions for topical human products (e.g., Soolantra cream) or for other branded human ivermectin formulations, the current, complete FDA labeling documents should be consulted directly because the provided reporting here does not reproduce every dosing paragraph [4].