Where can I find FDA-approved prescribing information for branded and generic ivermectin online?
Executive summary
If you want FDA‑approved prescribing information (the official “label” or Prescribing Information) for branded and generic ivermectin, the FDA’s Drugs@FDA database and related FDA pages are the authoritative starting points; the FDA explicitly directs users to Drugs@FDA for the most recent Prescribing Information [1]. Third‑party sites such as Drugs.com provide package inserts for specific products (e.g., ivermectin lotion) but derive those documents from FDA or manufacturer materials [2].
1. Where the FDA says to look: Drugs@FDA is the canonical source
The FDA’s own guidance for “most recently approved Prescribing Information (or Label)” points readers to the Drugs@FDA portal, where you can search by drug name, active ingredient, or application number to retrieve approved labeling and related approval documents [1]. For patient‑ and provider‑facing summaries about ivermectin’s uses and limitations, the FDA’s consumer guidance page on ivermectin and COVID‑19 reiterates the agency’s regulatory stance and safety warnings [3].
2. What you’ll find on those FDA pages — and what they show about uses
On Drugs@FDA you should expect to find the official FDA‑approved indications (e.g., antiparasitic uses), dosing, contraindications, adverse reactions, and the formal Prescribing Information [1]. The FDA consumer page stresses that ivermectin is not authorized or approved to prevent or treat COVID‑19 and warns about dangerous dosing and veterinary products, indicating the scope of current FDA‑approved human uses [3].
3. Examples available outside FDA — package inserts and product pages
Commercial medical information sites host package inserts and prescribing information that mirror FDA or manufacturer documents. For instance, Drugs.com hosts the ivermectin lotion prescribing information (indicated for head lice in patients 6 months and older), including patient counseling and reporting details that reference FDA labeling conventions [2]. Such pages are useful for quick access but originate from manufacturer submissions or FDA documents.
4. Branded vs. generic labels — what differs and how to find each
Available sources instruct you to search Drugs@FDA by drug name or active ingredient; that same database includes approval histories for specific NDA (branded) and ANDA (generic) products, so you can retrieve the exact Prescribing Information tied to a particular marketed product [1]. Third‑party pages (e.g., Drugs.com) may present a single “package insert” for a formulation (topical lotion, oral tablets) rather than listing every brand and generic separately [2].
5. Why context matters: state OTC laws and safety warnings
Several outlets report that state legislatures in 2025 passed laws allowing over‑the‑counter sales of ivermectin in some states, but that does not change the FDA’s approved indications or national labeling; the FDA continues to warn against using ivermectin for COVID‑19 and against taking veterinary formulations [4] [3]. Journalistic reporting shows pharmacists and manufacturers emphasizing adherence to FDA‑approved prescribing information despite shifting state rules [4].
6. Practical steps to obtain the official label online
1) Go to the FDA Drugs@FDA site and search “ivermectin” or the product’s NDA/ANDA number to download the current Prescribing Information [1]. 2) Consult the FDA consumer page for high‑level guidance and safety statements [3]. 3) For product‑specific inserts (e.g., ivermectin lotion), reputable drug information sites such as Drugs.com mirror the official label and can be used as an additional reference [2]. The FDA page explicitly directs users to Drugs@FDA for the most up‑to‑date labeling [1].
7. Competing viewpoints and limitations in reporting
Reporting shows debate over accessibility: some state laws aim to make ivermectin OTC while FDA and manufacturers caution use only within approved indications and doses; pharmacists in affected states reported reluctance to sell OTC without further FDA guidance [4] [1]. Available sources do not mention any FDA action that changes the nationwide approved indications to include COVID‑19; instead the FDA maintains that ivermectin is not authorized for COVID‑19 [3]. If you need a copy of a specific branded or generic product’s label and it’s not on Drugs@FDA, available sources do not mention alternative official federal repositories beyond the FDA guidance to use Drugs@FDA [1].
8. Quick caveats on third‑party and historical context
Third‑party summaries (news sites, drug information aggregators) are convenient but can lag or paraphrase the formal label; the authoritative source remains the FDA’s own documents [1] [2]. Historical coverage also documents large spikes in off‑label ivermectin prescribing during the COVID‑19 pandemic and public health warnings about misuse and toxicity, which is why checking the current FDA label and consumer alerts matters when interpreting available formulations and uses [5] [3].