Ivermectin - Whitezenith Inc

Manufacturer
Whitezenith Inc
Effective date
2026-10-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-21 00:01:07

Label at a glance#

ProductIvermectin
Active ingredientIVERMECTIN
Label structure9 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: 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 ha...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ivermectin 0.5%

OTC - PURPOSE SECTION

Lice treatment

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.

WARNINGS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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.

Directions

INDICATIONS & USAGE 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

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.

Other information

OTHER SAFETY INFORMATION

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 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

117 g Tube Carton117 g Tube Cartonpackagepackage

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
88060-00188060-001-01

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 44.

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
2026-10-15 13:18:302026-09A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06c2088c7a36db…
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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvermectinIVERMECTINYYBA Corp59ea9767-2e0b-ebc2-e063-6294a90ab9042026-08-25WarningsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINAzurity Pharmaceuticals, Inc.58c9cc4d-b1f3-1b6f-e063-6294a90ab5972026-08-11WarningsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
Head Lice Treatment Ivermectin Lotion118mLIVERMECTINYunqi Cosmetics (Shenzhen) Co., Ltd56a37d8f-c1b8-465a-e063-6394a90aa3342026-07-15WarningsName fallback
generic name: IVERMECTIN
SYNTHABIO IvermectinIVERMECTINShenzhen Xuyan Technology Co., Ltd.540d6a24-68bf-50c8-e063-6294a90aaa302026-06-22WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINAmerisourceBergen4e924212-cd7b-ccd9-e063-6394a90afb952026-04-16WarningsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINAjanta Pharma USA Inc.1fb17bc2-9192-4a0b-a3ee-fda9db035daa2026-04-09Warnings, Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINA-S Medication Solutions104a5045-94b1-4022-bc49-719521f30f0d2026-03-03Warnings, Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINViona Pharmaceuticals Inc2de5ee45-0465-4996-ac00-5bdd352b4ed72026-02-27Warnings, Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINZydus Lifesciences Limited6d626814-5288-441c-9508-f7f5130feceb2026-02-27Name fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINSun Pharmaceutical Industries, Inc.dd2c66e6-bd50-46df-a335-26215d02d13b2025-12-22WarningsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINEdenbridge Pharmaceuticals LLC.847a1dd7-d65b-4a0e-a67d-d90392059dac2025-12-18Warnings, Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINBryant Ranch Prepack1061e454-d1dc-4293-b18d-9c8717fbbb402025-10-23Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINCVS Pharmacy326e85c6-b95f-6aa8-e063-6294a90a49852025-06-20WarningsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINActavis Pharma, Inc.de9253c3-7d66-47fe-8ad7-8c0d4ee8ebda2025-05-31Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
RID One and DoneIVERMECTINOystershell Consumer Health, Inc.731a15f8-3578-4a95-b04c-aa6cf44a46652025-03-07WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINAdvagen Pharma Ltde88adfbc-e375-4fea-827e-6ec51ed6fd0a2025-01-29Warnings, Adverse reactionsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IvermectinIVERMECTINWALMART INC.1608ec4a-2af4-4a43-a83f-5b25937068d12025-01-09WarningsName fallback
brand name: Ivermectin
generic name: IVERMECTIN
IVERMECTINIVERMECTINDR. REDDY'S LABORATORIES, INC.4cb062d7-0597-4e92-b2f6-7129a95e95002024-11-19Warnings, Adverse reactionsName fallback
brand name: IVERMECTIN
generic name: IVERMECTIN
SOOLANTRAIVERMECTINGalderma Laboratories, L.P.b1d5b166-ab06-4ab5-b0c6-31126238118a2024-10-24Adverse reactionsName fallback
generic name: IVERMECTIN
STROMECTOLIVERMECTINMerck Sharp & Dohme LLC681888c9-af79-4b7d-ae80-c3f4f6f1effd2024-09-20Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN

Reported adverse events (FAERS/openFDA)#

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