What are the full FDA prescribing instructions (package insert) for ivermectin tablets and topical ivermectin?

1. What the regulators approved: indications and product forms

Oral ivermectin tablets (branded Stromectol) are FDA‑approved to treat intestinal strongyloidiasis and onchocerciasis (river blindness) in humans ^{[1] [2]}, while topical ivermectin formulations include a 0.5% lotion indicated for head lice in patients 6 months and older (Sklice OTC) and a 1% cream indicated for inflammatory lesions of rosacea (Soolantra) ^{[3] [4] [6]}.

2. Tablet dosing and administration (package‑insert essentials)

The tablet label directs dosing keyed to body weight, typically a single dose of approximately 150–200 micrograms per kilogram for parasitic indications, with Stromectol commonly supplied as 3‑mg tablets and recommended to be taken on an empty stomach with water; detailed tabular dosing by weight appears in the FDA label ^{[2] [7]}. The NDA and FDA review materials and product labels state tablets are formulated to provide the target mcg/kg dose and that bioequivalence determinations underpin approved generics ^{[2] [8]}.

3. Topical products: how to use the lotion and the cream

The ivermectin 0.5% lotion for head lice is for topical use only, applied to dry hair in a single treatment sufficient to coat hair and scalp (up to one tube), and is available over‑the‑counter with patient instructions on the package insert ^{[3] [5]}. Ivermectin 1% cream for rosacea is applied once daily to affected facial areas using a pea‑sized amount per area, and patient counseling information is included in the prescribing information ^{[4] [9]}.

4. Warnings, adverse reactions and off‑label cautions

Package inserts and FDA guidance emphasize that ivermectin tablets and topical forms have specific approved uses and dosing, and the FDA warns clinicians and the public that ivermectin is not authorized for prevention or treatment of COVID‑19 unless used in a legitimate off‑label clinical judgment by a licensed prescriber ^{[1] [10]}. Common topical adverse reactions reported in trials of the cream include skin burning and irritation (≤1% incidence), while systemic overdoses of ivermectin (noted in commentary and legal guidance) can cause gastrointestinal, neurologic and cardiovascular toxicity; serious adverse events should be reported to FDA MedWatch ^{[4] [11] [5]}.

5. Pharmacology, storage and formulation notes from the labels

The tablet chemistry notes describe ivermectin as a crystalline powder with specific inactive ingredients in 3‑mg tablets and pharmacokinetic data showing peak plasma concentrations around four hours after dosing in fasting volunteers ^{[2] [7]}. Topical lotion/cream labels state they are for cutaneous use only, list storage conditions (e.g., 20°–25°C for the lotion) and instruct not to use orally, ophthalmically or intravaginally; individual product inserts include full patient counseling points ^{[3] [4]}.

6. Limits of public reporting and practical implications

The available sources provide the authoritative highlights of the package inserts and FDA consumer guidance, but the full, legally binding label contains detailed tables and labeling sections that clinicians consult for exact weight‑by‑weight dosing, lab interaction data and complete contraindications; those full inserts should be referenced directly via FDA or the full product package insert for prescribing decisions ^{[2] [12]}. Alternative viewpoints exist: FDA and medical societies caution against non‑prescribed use for COVID‑19 and against using veterinary formulations, while clinicians retain the ability to prescribe human ivermectin off‑label when judged appropriate ^{[1] [11]}.