Ivermectin

Manufacturer
Rite Aid Corporation | Taro Pharmaceutical Industries Ltd.
Effective date
2024-08-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:17:07

Label at a glance#

ProductIvermectin
Active ingredientIVERMECTIN
Label structure11 sections

Dosage and administration

Important: Read warnings 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: 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 ...

Storage and handling

TAMPER EVIDENT: DO NOT USE IF THE TAMPER SEAL ON THE TUBE HAS BEEN BROKEN. store at room temperature 68º-77ºF (20º-25ºC) do not freeze keep carton and see Consumer Information Leaflet and warnings before use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ivermectin 0.5%

Purpose

OTC - PURPOSE SECTION

Lice treatment

Use

INDICATIONS & USAGE SECTION

treats head lice

Warnings

WARNINGS SECTION

For external use only. Use only on the scalp.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs
  • rash develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Important: Read warnings 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

SPL UNCLASSIFIED SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • your hair and scalp must be DRYbefore 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

SPL UNCLASSIFIED SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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.

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF THE TAMPER SEAL ON THE TUBE HAS BEEN BROKEN.
  • store at room temperature 68º-77ºF (20º-25ºC)
  • do not freeze
  • keep carton and see Consumer Information Leaflet and warnings before use

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate and stearyl alcohol.

Questions?

OTC - QUESTIONS SECTION

1-866-923-4914

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL - 117 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active
ingredient in Sklice ®*

NDC 11822-4230-8

carton-01carton-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1246673ivermectin 0.5 % Topical LotionPSN3
1246673ivermectin 5 MG/ML Topical LotionSCD3
1246673ivermectin 0.5 % Topical LotionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IVERMECTIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7fd951fe-040a-0b64-2bea-eefc6aa4fc54Product name220250515
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5b0ed980-56ce-7dd0-fb86-ff54be67c2e6Product name220200925
eed31638-1288-4eb6-a55c-5fc014dca98dProduct name320200728
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-4230-8Ivermectin1 in 1 CARTONLOTION13
11822-4230-8Ivermectin117 g in 1 TUBELOTION1173

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4230IVERMECTIN LOTION [RITE AID CORPORATION]3Current NDC, Legacy NDC, 2 package rows20240814_3a2eb7f3-b72b-435c-a609-ce7050cccff4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-423011822-4230-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210720-001IVERMECTINIVERMECTIN0.5%LOTION / TOPICAL2020-05-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-0684e616aacf4f…
2026-08-18 06:07:402026-07A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-064b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210720-001IVERMECTIN0.5%LOTION / TOPICALAB2020-05-06c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-11-12 02:37 UTC2020-11A210720-001AB1c0c555d07b60…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2021-12-28 21:50 UTC2021-12A210720-001PC2021-05-29782e0a99824c…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvermectinIVERMECTINRite Aid Corporation3a2eb7f3-b72b-435c-a609-ce7050cccff42024-08-12WarningsExact identifier
ndc (package): 11822-4230-8
ndc (product): 11822-4230
ndc11 (package): 11822423008
spl id: 1f81eef3-2ffd-2759-e063-6394a90a3ec2
spl set id: 3a2eb7f3-b72b-435c-a609-ce7050cccff4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.