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Ivermectin
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Ivermectin | 5 mg/g | 311207 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 210720-001 | IVERMECTIN | LOTION | IVERMECTIN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUse treats head lice
Purpose
openFDA Drug LabelingPurpose Lice treatment
Dosage and Administration
openFDA Drug LabelingDirections 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingActive ingredient Ivermectin 0.5%
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.