OZIPCO IVERMECTIN LOTION 0.5% LICE TREATMENT

Manufacturer
Fast Sold LLC
Effective date
2026-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-29 01:02:46

Label at a glance#

ProductOZIPCO IVERMECTIN
Active ingredientIVERMECTIN
Label structure16 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 for lice and/or nits (eggs). Hair and scalp must be dry before applying product. Apply product directly to dry hair and scalp. Completely cover scalp and hair closest to the scalp first, then apply outward toward the ends....

Storage and handling

TAMPER EVIDENT: DO NOT USE IF THE TAMPER SEAL ON THE TUBE HAS BEEN BROKEN. Store at room temperature 68°F to 77°F (20°C to 25°C). Do not freeze. Keep carton and see Consumer Information Leaflet and warnings before use.

Label contents#

Full prescribing information#

Drug Listing Data Elements

SPL product data elements section

OZIPCO Ivermectin Lotion 0.5% Lice Treatment

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

Pregnancy or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

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 all household members for lice and/or nits (eggs).

Hair and scalp must be dry before applying product. Apply product directly to dry hair and scalp. Completely cover scalp and hair closest to the scalp first, then apply outward toward the ends. Use only the amount needed to completely cover hair and scalp, up to 1 entire tube. Rub product throughout hair.

Allow product to stay on hair and scalp for 10 minutes after it has been applied. After 10 minutes, rinse completely using only water.

After rinsing, dry and style as usual. Wait 24 hours before applying shampoo.

Wash hands after applying product. Nit combing is not necessary. This is a single-use product. Discard tube after use. If infestation continues, see a doctor for other treatments.

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 68°F to 77°F (20°C to 25°C). 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, stearyl alcohol

Other labeling information

SPL UNCLASSIFIED SECTION

Questions or comments? 1-502-922-6432

DISTRIBUTED BY: Fast Sold LLC, Avocado Ave Unit 5, Melbourne, Florida 32935, USA.

www.fastsoldllc.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OZIPCO Ivermectin Lotion 0.5% Lice Treatment

NDC 86241-113-01

NET WT. 4 oz (117 g)

OZIPCO Ivermectin Lotion 0.5% 117 g carton labelOZIPCO Ivermectin Lotion 0.5% 117 g carton label

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86241-11386241-113-01

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
generic name: IVERMECTIN
IvermectinIVERMECTINAzurity Pharmaceuticals, Inc.58c9cc4d-b1f3-1b6f-e063-6294a90ab5972026-08-11WarningsName fallback
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
generic name: IVERMECTIN
IvermectinIVERMECTINAjanta Pharma USA Inc.1fb17bc2-9192-4a0b-a3ee-fda9db035daa2026-04-09Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINA-S Medication Solutions104a5045-94b1-4022-bc49-719521f30f0d2026-03-03Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINViona Pharmaceuticals Inc2de5ee45-0465-4996-ac00-5bdd352b4ed72026-02-27Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINZydus Lifesciences Limited6d626814-5288-441c-9508-f7f5130feceb2026-02-27Name fallback
generic name: IVERMECTIN
IvermectinIVERMECTINSun Pharmaceutical Industries, Inc.dd2c66e6-bd50-46df-a335-26215d02d13b2025-12-22WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINEdenbridge Pharmaceuticals LLC.847a1dd7-d65b-4a0e-a67d-d90392059dac2025-12-18Warnings, Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINBryant Ranch Prepack1061e454-d1dc-4293-b18d-9c8717fbbb402025-10-23Adverse reactionsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINCVS Pharmacy326e85c6-b95f-6aa8-e063-6294a90a49852025-06-20WarningsName fallback
generic name: IVERMECTIN
IvermectinIVERMECTINActavis Pharma, Inc.de9253c3-7d66-47fe-8ad7-8c0d4ee8ebda2025-05-31Adverse reactionsName fallback
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
generic name: IVERMECTIN
IvermectinIVERMECTINWALMART INC.1608ec4a-2af4-4a43-a83f-5b25937068d12025-01-09WarningsName fallback
generic name: IVERMECTIN
IVERMECTINIVERMECTINDR. REDDY'S LABORATORIES, INC.4cb062d7-0597-4e92-b2f6-7129a95e95002024-11-19Warnings, Adverse reactionsName fallback
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.