One ivermectin product in the United States is genuinely sold over the counter: ivermectin lotion 0.5%, the head lice treatment first marketed as Sklice. FDA approved a complete switch of Sklice from prescription to nonprescription status on 27 October 2020, and today the brand and its store-brand equivalents sit on open retail shelves with a Drug Facts panel instead of a prescribing information leaflet. Nothing else containing ivermectin — not the tablets, not the 1% cream — carries over-the-counter marketing status in FDA's Orange Book. If you are trying to understand how OTC status works across the whole ivermectin drug family, this single lotion is the entire answer.

Counted row by row from the FDA Orange Book product file (data files dated 11 September 2026, retrieved 28 September 2026), there are 17 human ivermectin product rows: 13 prescription, 2 over the counter, 2 discontinued. Both OTC rows are the same thing — ivermectin 0.5% topical lotion for head lice. This page sets out what that label actually says, what it does not say, and why an OTC lotion carries no implication whatsoever for the legal status of ivermectin tablets.

Key takeaways

  • Ivermectin lotion 0.5% (Sklice, NDA 202736) is the only FDA-approved ivermectin product with over-the-counter status; the switch was approved 27 October 2020 under supplement S-006.
  • Its entire labeled Use, in the Drug Facts panel, is three words: "treats head lice." The label does not mention scabies, rosacea or Demodex — those terms appear zero times in it.
  • The Drug Facts label says do not use on children under 6 months of age, and do not use on lice in eyebrows or eyelashes.
  • All approved generic and store-brand OTC ivermectin lotions in FDA's listing data trace to a single application, Taro's ANDA 210720.
  • Every ivermectin tablet row in the Orange Book is prescription or discontinued. The lotion's OTC status changes nothing about tablets.

The short answer: one ivermectin product is genuinely OTC, and it is not a tablet

A parent parting a young child's hair to check the scalp for head lice at a kitchen table

The FDA Orange Book, current through September 2026, records the marketing status of every approved drug product. Across the ivermectin rows, the split is 13 prescription, 2 over the counter, 2 discontinued. The two OTC entries are Sklice (NDA 202736) and Taro's generic (ANDA 210720), both ivermectin lotion 0.5% for topical use.

By contrast, the oral tablets — eight applications, ten product rows — are nine prescription rows plus one discontinued row, and zero OTC. Prescription status is a federal labeling consequence: under 21 U.S.C. 353(b)(4)(A), a prescription drug is misbranded if its label does not bear at minimum the symbol "Rx only," which is exactly what the Stromectol carton bears.

What Sklice is approved for, and for what ages

A pharmacist moving plain cartons from behind the prescription counter out to an open retail shelf

On the current DailyMed label (Azurity Pharmaceuticals, updated 11 July 2024), the Drug Facts panel reads: Active ingredient, Ivermectin 0.5%; Purpose, Lice treatment; Use, treats head lice. That is the whole indication.

Age and body-site limits

  • Do not use on children under 6 months of age.
  • Do not use near the eyes, inside the nose, ear, mouth, or vagina.
  • Do not use on lice in eyebrows or eyelashes — the label says to see a doctor if lice are present in these areas.
  • The adjacent warnings read "For external use only" and "Use only on the scalp."

A full-text count of the label's XML on 28 September 2026 found scabies, rosacea, Demodex, mite and pediculosis each appearing zero times. Head lice is the only condition on this label.

The Rx-to-OTC switch: what changed, when, and what the FDA required

A kitchen timer and a plain lotion tube on a bathroom counter during a ten-minute lice treatment

Sklice was approved on 7 February 2012 as a prescription product, indicated as "a pediculicide... for the topical treatment of head lice infestations in patients 6 months of age and older," per the original 2012 label. Drugs@FDA classifies that original approval as Type 3 — New Dosage Form.

The change came in the FDA supplement approval letter of 27 October 2020, which states that the supplement "provides for a complete switch of Sklice® (ivermectin) lotion, 0.5% from prescription to over-the-counter status." Complete means no prescription version remained. FDA recorded the supplement under the Efficacy class, and required the final printed labeling to match the enclosed labeling in Drug Facts format.

Two points about the route matter. First, this was an application-based switch, not a monograph listing: FDA's small-business guidance on OTC regulation describes an efficacy supplement to an approved NDA as the mechanism for switching a product in its entirety. Second, ivermectin is not a permitted monograph pediculicide ingredient at all: 21 CFR 358.610 permits only pyrethrum extract (0.17 to 0.33 percent pyrethrins) combined with piperonyl butoxide (2 to 4 percent). FDA also notes that for nonprescription approvals outside the monograph it typically requires studies of consumers' ability to use the product from the label alone.

Reading the OTC Drug Facts label against the old prescription label

A store employee restocking a row of identical plain store-brand lice lotion cartons on a pharmacy shelf
Element 2012 prescription label Current OTC Drug Facts label
Indication / Use "a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older" "treats head lice"
Age handling Stated as part of the indication Stated as a "Do not use" bullet: under 6 months of age
Format Highlights plus full prescribing information Drug Facts panel: Active ingredient, Purpose, Use, Warnings, Directions
Status Rx only Nonprescription, since 27 October 2020

One genuine source of confusion: the carton still advertises its origin. The Sklice carton (NDC 24338-185-04, 117 g / 4 oz tube) reads "Original Prescription Strength — Now available without a prescription!" and the CVS store-brand carton is printed "PRESCRIPTION STRENGTH." Those phrases describe the concentration's history, not the product's current legal status, which is over the counter.

How it compares with the other approved head lice treatments, by label

Product Route to market Status What its label covers
Ivermectin lotion 0.5% (Sklice, NDA 202736) NDA, Rx-to-OTC switch 27 Oct 2020 OTC Use: "treats head lice"
Ivermectin lotion 0.5% generic (ANDA 210720, Taro) ANDA, approved 6 May 2020 OTC Same active ingredient and strength
Pyrethrum extract with piperonyl butoxide OTC monograph, 21 CFR 358.610 OTC Pediculicide actives permitted by the monograph
Permethrin lice products Sold over the counter in US pharmacies OTC Strength and directions not verified against a primary label for this article — read the Drug Facts panel on the pack
Ivermectin cream 1% (Soolantra, NDA 206255) NDA, approved 19 Dec 2014 Rx "inflammatory lesions of rosacea" — not lice
Ivermectin tablets (Stromectol, NDA 050742, and generics) NDA / ANDAs Rx Intestinal strongyloidiasis and onchocerciasis

On the "permethrin vs ivermectin for lice" question, the honest framing is regulatory, not comparative: both are available without a prescription, they reached that position by different routes, and this article does not claim one works better than another. No head-to-head comparison is made on either product's approved labeling.

One application versus repeat treatment: what each label states

The Sklice Directions instruct applying the product to dry hair and scalp, then: "allow product to stay on your hair and scalp for 10 minutes after it has been applied. Use a timer or clock." After 10 minutes, rinse completely using only water; dry and style as usual; wait 24 hours before applying shampoo. The label states it is a single-use product and to discard the tube after use, and the carton prints "No second application required."

Other lice products carry their own directions and their own retreatment schedules. Those are set on each product's Drug Facts panel, and the only way to use them correctly is to read the specific pack you bought — do not carry the 10-minute, single-use pattern across to a different active ingredient.

Nits, eggs and combing: what the labels claim and what they do not

The Sklice carton states "No nit combing required," and the label's directions do not call for nit combing. That is a claim about the procedure, not a promise about outcomes. The Use statement on the Drug Facts panel is limited to "treats head lice" — it makes no separate labeled claim about eggs, and it does not promise eradication in any particular household.

Two practical limits sit on the same label: it is for the scalp only, and lice in eyebrows or eyelashes are explicitly outside its scope, with an instruction to see a doctor.

Brand, generic and store-brand availability

Three ivermectin lotion applications exist. Sklice holds NDA 202736 (packaged by Azurity Pharmaceuticals; manufactured by Delpharm Montréal Inc.). Taro's ANDA 210720 was approved 6 May 2020 — before the brand's own switch — and carries OTC status. Teva's ANDA 212485, approved 21 March 2022, is listed as discontinued in the September 2026 Orange Book file.

That leaves one generic application supplying the shelf. Checked against DailyMed labels and FDA's listing data on 28 September 2026, every private-label and generic OTC ivermectin lotion traces to ANDA 210720, including the store brands from CVS Pharmacy, Walgreens, Walmart and Rite Aid, plus the branded RID One & Done from Oystershell Consumer Health. If you are finding it on a chain pharmacy shelf, the "Sklice generic" you are holding is almost certainly Taro's product under someone else's carton.

One caution. DailyMed also carries ivermectin 0.5% topical listings filed as OTC monograph drugs rather than under any approved application, from overseas firms citing monograph M031 — and ivermectin is not an M031 pediculicide active ingredient. A listing in FDA's database is not an FDA approval.

Why an OTC lotion tells you nothing about the prescription status of tablets

Marketing status is decided product by product, application by application. Stromectol's label (revised 09/2024) is a prescription label indicated for two parasitic infections — intestinal strongyloidiasis and onchocerciasis — and its carton reads "Rx only." Soolantra, the prescription topical cream, is indicated only for inflammatory lesions of rosacea. Neither changed when the lotion switched. The federal test for prescription status in 21 U.S.C. 353(b)(1) is applied to a drug as it is used and labeled, not to a molecule. Our overview of every form on the market sets the three approved human dosage forms — tablet, cream, lotion — side by side.

State law is a separate layer again. Verified against each state's own legislative record, seven states have enacted ivermectin access laws — laws under which a pharmacy can supply human ivermectin without a patient-specific prescription: Arkansas (Act 396 / SB 189, Ark. Code Ann. § 20-7-147), Idaho (S 1211, in force 14 April 2025), Iowa (HF 2676, in force 1 July 2026), Louisiana (Act 464, in force 20 June 2025), Missouri (SB 878, in force 28 August 2026), Tennessee (Public Chapter 908, in force 22 April 2022) and Texas (HB 25, in force 4 December 2025). Two of the seven put nobody at the counter (Arkansas and Idaho); the other five route the decision through a pharmacist or a pharmacy. North Dakota is often added to that list, but its statute (HB 1514, N.D.C.C. § 43-15-42.4, in force 15 November 2021) is a protection law, not an access law: it shields the prescriber or pharmacist from discipline or liability and creates no new route for a patient, so a prescription is still required there. Those statutes operate on state dispensing rules; they do not make any product federally over the counter.

Finally, animal ivermectin. Products such as equine paste and cattle injectables are labeled for animal use only and are not approved for people; FDA's standing recommendation, in its April 2020 letter to stakeholders, is that people should never take animal drugs, because their safety and effectiveness have been evaluated only in the species they are labeled for. FDA also states it has not authorized or approved ivermectin for preventing or treating COVID-19 in humans or animals.

Cost and coupons, at a high level

US retail and cash prices for ivermectin products could not be verified from any primary source for this article; coupon sites such as GoodRx and Drugs.com are closed to automated verification, so any figure from them should be attributed to that site and its own date, not treated as established. What can be sourced is CMS's National Average Drug Acquisition Cost, which is what pharmacies pay, not what you pay at the register.

In the CMS NADAC file effective 23 September 2026: ivermectin 0.5% lotion, $1.23937 per gram — and it is the one ivermectin record CMS flags as OTC. Generic ivermectin 1% cream is $2.74609 per gram; the 3 mg tablet, $1.99423 each; the 6 mg tablet, $9.80491 each. For a broader breakdown of what it costs by form, see our pricing page. Because the lotion is nonprescription, the amount you pay at a store is set by the retailer, and store brands under ANDA 210720 are a like-for-like alternative to the brand.

Frequently asked questions

Do I need a prescription for Sklice?

No. FDA approved a complete switch to over-the-counter status on 27 October 2020, and the current label is a Drug Facts label, not a prescription label.

Is the OTC lotion weaker than the old prescription version?

The active ingredient statement is Ivermectin 0.5% on the current OTC label, and the 2012 prescription approval was also for lotion 0.5% under the same application, NDA 202736. The carton's "Original Prescription Strength" wording refers to that.

Can I use ivermectin lotion on a baby?

The label says do not use on children under 6 months of age. It also says not to use it near the eyes or on lice in eyebrows or eyelashes, and to see a doctor if lice are present in those areas.

Is there a Sklice generic?

Yes. Taro's ivermectin lotion 0.5% was approved under ANDA 210720 on 6 May 2020, and the store-brand cartons sold by major chains are marketed under that same application.

Can the lotion be used for scabies or rosacea?

Its label covers head lice only; scabies, rosacea and Demodex appear nowhere in it. No FDA-approved ivermectin product in any dosage form carries a scabies indication, and the 1% cream's indication is limited to inflammatory lesions of rosacea.

Does OTC lice lotion mean ivermectin tablets are now OTC?

No. As of the September 2026 Orange Book, no oral ivermectin tablet row carries over-the-counter status; nine are prescription and one is discontinued.

Sources