Are there approved human formulations of ivermectin for skin application?

1. What is approved for human skin: rosacea and head lice

Clinical and regulatory reporting identifies a topical ivermectin 1% cream approved for treating inflammatory lesions of papulopustular rosacea (commonly marketed as Soolantra) and a 0.5% ivermectin lotion (Sklice) approved for head lice; both are presented in U.S.-facing coverage and drug directories as FDA‑approved human topical formulations ^{[1] [2]}.

2. How regulators frame approved indications vs. other uses

The U.S. Food and Drug Administration’s public-facing guidance and fact checks note that ivermectin has specific approved human uses (antiparasitic tablets, and topical formulations for particular skin conditions) but stress the agency has not approved ivermectin for COVID‑19; reporting reiterates that topical products are approved for defined skin indications, not for viral disease ^{[5] [6]}.

3. Off‑label use, case reports and clinical studies—what sources mention

Journalistic and dermatology commentary note topical ivermectin is used off‑label for several inflammatory dermatoses (for example, refractory scabies, perioral dermatitis, seborrheic dermatitis and acne in small studies or case series). These uses are described as emerging or reported in small studies or clinical practice rather than as new FDA approvals ^{[1] [7]}.

4. Distinction between human‑approved topical products and veterinary “pour‑ons”

Federal records show FDA approvals for topical ivermectin in animals (for example, a 0.5% pour‑on for cattle under an ANADA) and veterinary product labels and Dailymed entries make clear those are animal drugs with different instructions and risks ^{[3] [4]}. Dermatology commentary warns patients against substituting veterinary formulations for human creams because concentrations and excipients differ; one dermatology post specifically contrasted a 1% human cream with a 1.8% horse paste circulating online ^[7].

5. Label strength, dosing and formulation matter

Sources emphasize that human topical products have specific concentrations and regimens studied in trials—for instance, Sklice’s approval was supported by two phase III trials using a 0.5% lotion applied to the dry scalp then rinsed after 10 minutes ^[2]. A dermatology blog contrasted the FDA‑approved 1% topical dose for rosacea with higher‑concentration veterinary pastes being misused by patients ^[7].

6. Public confusion and misinformation drivers

Multiple fact checks and news items document confusion about ivermectin’s approvals: while ivermectin is FDA‑approved for certain human parasitic infections and some topical skin indications, false or partial claims have circulated (for example, that ivermectin is broadly FDA‑approved for COVID‑19). Fact checking pieces explicitly separate approved topical uses (rosacea, head lice) from unapproved COVID‑19 claims ^{[5] [6] [8]}.

7. Practical takeaway and limitations of available reporting

Available sources confirm human topical ivermectin products are FDA‑approved for specific skin conditions (rosacea 1% cream; head lice 0.5% lotion) and document veterinary topical approvals, but they do not provide a comprehensive list of all marketed brand names or global regulatory variations—those details are not found in the current reporting provided here ^{[1] [2] [3]}. They also document off‑label clinical use but do not offer definitive efficacy judgments or detailed safety comparisons for every off‑label indication ^{[1] [7]}.

If you want, I can:

• pull the exact FDA approval letters and label text for Soolantra and Sklice (if you provide or allow more sources), or
• summarize safety advisories the FDA issued about misuse of veterinary ivermectin versus human topical products (current sources note the distinction but do not reproduce full advisories) ^{[7] [4]}.