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Ivermectin

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Ivermectin
Generic name
Ivermectin
Dosage form
Lotion
Route
Topical
Marketing category
ANDA · ANDA
Labeler
CVS Pharmacy
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
10
Packages
10
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ivermectin 5 mg/g 311207 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Lotion
Route of administration
Topical
Presentations
20

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Antiparasitic [EPC] EPC 3 members — no class page
Pediculicide [EPC] EPC 5 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
210720
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 6, 2020
Sponsor
TARO
Products on application
1
Submissions recorded
2
Products approved under application 210720.
Product Trade name Form Strength Ingredient Status TE Flags
210720-001 IVERMECTIN LOTION IVERMECTIN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 210720.
Type No. Action Status Date Review
Supplement 2 Labeling Approved January 6, 2021 Standard
Original application 1 Approved May 6, 2020 Standard

Review documents

  • 0 · Original application · June 4, 2020

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241017). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20241017 HUMAN OTC DRUG · 20240812

Indications and Usage

openFDA Drug Labeling

Use treats head lice

Purpose Lice treatment

Dosage and Administration

openFDA Drug Labeling

Directions Important: Read warnings on carton before use. children 6 months of age to under 12 years of age: an adult should supervise use. adults and children 6 months of age and over: Inspect all household members should be checked by another person for lice and/or nits (eggs) use a magnifying glass in bright light to help you see the lice and/or nits (eggs) use a tool, such as a comb or two unsharpened pencils, to lift and part the hair look for tiny nits near the scalp, beginning at the back of the neck and behind the ears examine small sections of the hair (1-2 inches wide) at a time unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched. If either lice or nits (eggs) are found, treat with product. Treat your hair and scalp must be DRY before applying product use the top of cap to break the tamper seal on the tube apply product directly to dry hair and scalp completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair use only amount needed to completely cover hair and scalp, up to 1 entire tube, and discard the remaining rub product throughout your hair it is important to completely cover your entire head so that all lice and eggs are exposed to the lotion. Be sure that each hair is coated from the scalp to the tip. Wait and rinse allow product to stay on your hair and scalp for 10 minutes after it has been applied. Use a timer or clock. Start timing after you have completely covered your hair and scalp with product. After 10 minutes, rinse product completely from your hair and scalp using only water after rinsing, dry and style as usual. Wait 24 hours before applying shampoo. After treatment wash your hands after applying product nit combing is not necessary when treating with product for it to work, but if desired, a fine-tooth comb or special nit comb may be used to remove dead lice and nits this is a single use product. Discard tube after use. Do not use again on the same person and same lice infestation without talking to a healthcare provider first if infestation continues, see a doctor for other treatments machine wash any bedding and clothing used by anyone having lice. Machine wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes. After finishing treatment with lice medicine, check everyone in your family for lice after one week. Consider treatment for those who have lice.

Warnings For external use only. Use only on the scalp. Do not use on children under 6 months of age near the eyes inside the nose, ear, mouth, or vagina on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas. Ask a doctor before use if you have any skin conditions or sensitivities are pregnant or plan to become pregnant. It is not known if product can harm your unborn baby are currently or planning to breastfeed. Avoid getting product on your breast to help prevent contact by your baby. When using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into eyes, gently flush with water eye redness, soreness, or irritation can occur dandruff, dry skin, or burning sensation of the skin can occur. Stop use and ask a doctor if breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs rash develops. If pregnant or breastfeeding , ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Do not use on children under 6 months of age near the eyes inside the nose, ear, mouth, or vagina on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have any skin conditions or sensitivities are pregnant or plan to become pregnant. It is not known if product can harm your unborn baby. are currently or planning to breastfeed. Avoid getting product on your breast to help prevent contact by your baby.

Stop use and ask a doctor if breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs rash develops.

Active Ingredient

openFDA Drug Labeling

Active ingredient Ivermectin 0.5%

Adverse event reports

Source: openFDA FAERS
6,299
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IVERMECTIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
46122-827-36 46122-827 AmerisourceBergen 1 TUBE in 1 CARTON (46122-827-36) / 117 g in 1 TUBE April 3, 2026
24338-119-45 24338-119 Azurity Pharmaceuticals, Inc. 1 TUBE in 1 CARTON (24338-119-45) / 117 g in 1 TUBE August 11, 2026
27854-334-01 27854-334 Belmora LLC 1 TUBE in 1 CARTON (27854-334-01) / 117 g in 1 TUBE August 12, 2024
51316-423-08 51316-423 CVS Pharmacy 1 TUBE in 1 CARTON (51316-423-08) / 117 g in 1 TUBE December 28, 2021
51316-985-08 51316-985 CVS Pharmacy 1 TUBE in 1 CARTON (51316-985-08) / 117 g in 1 TUBE June 20, 2025
11822-4230-8 11822-4230 Rite Aid Corporation 1 TUBE in 1 CARTON (11822-4230-8) / 117 g in 1 TUBE February 3, 2022
51672-4230-8 51672-4230 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-4230-8) / 117 g in 1 TUBE January 6, 2021
79903-154-01 79903-154 WALMART INC. 1 TUBE in 1 CARTON (79903-154-01) / 117 g in 1 TUBE December 27, 2022
0363-4230-08 0363-4230 Walgreen Company 1 TUBE in 1 CARTON (0363-4230-08) / 117 g in 1 TUBE December 28, 2021
73581-021-04 73581-021 YYBA Corp 1 TUBE in 1 CARTON (73581-021-04) / 117 g in 1 TUBE August 3, 2026
46122-827 46122-827 AmerisourceBergen — April 3, 2026
24338-119 24338-119 Azurity Pharmaceuticals, Inc. — August 11, 2026
27854-334 27854-334 Belmora LLC — August 12, 2024
51316-423 51316-423 CVS Pharmacy — May 6, 2020
51316-985 51316-985 CVS Pharmacy — June 20, 2025
11822-4230 11822-4230 Rite Aid Corporation — May 6, 2020
51672-4230 51672-4230 Sun Pharmaceutical Industries, Inc. — May 6, 2020
79903-154 79903-154 WALMART INC. — December 27, 2022
0363-4230 0363-4230 Walgreen Company — May 6, 2020
73581-021 73581-021 YYBA Corp — August 3, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.