FDA.reportPublic FDA data

83091-004

Manufacturer
Anhui Cao coral biology science and technology co., ltd
Effective date
2026-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-21 00:01:02

Label at a glance#

ProductNicovito Ivermectin Lotion.
Active ingredientIVERMECTIN
Label structure14 sections

Dosage and administration

Check hair for live lice before use. Apply enough lotion to thoroughly coat dry hair and scalp. Leave on for 10 minutes. Rinse thoroughly with water. Towel dry. No nit combing required*. Use only once per treatment cycle unless directed by a doctor.

Storage and handling

Store at 20°Cto 25°C (68°F to 77°F). Keep tightly closed. Do not freeze. Protect from excessive heat.

Label contents#

Full prescribing information#

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

Do not use

OTC - DO NOT USE SECTION

Do not use if you are allergic to ivermectinor any of the ingredients in this product.

When Using

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs,rinse thoroughly with water.
do not use on eyebrows or eyelashes.
do not use on broken or irritated scalp.

Stop Use

OTC - STOP USE SECTION

irritation, redness, or rash occurs.
condition persists or worsens.

Ask Doctor

OTC - ASK DOCTOR SECTION

irritation, redness, or rash occurs.
condition persists or worsens.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contacta Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Check hair for live lice before use.
Apply enough lotion to thoroughly coat dry hair
and scalp.
Leave on for 10 minutes.
Rinse thoroughly with water.
Towel dry. No nit combing required*.
Use only once per treatment cycle unless
directed by a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at 20°Cto 25°C (68°F to 77°F).
Keep tightly closed.
Do not freeze.
Protect from excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

​cedarwooddirect@outlook.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83091-004

11

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83091-00483091-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
IVERMECTIN8883YP2R6DACTIB
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CASTOR OILD5340Y2I9GIACT
CETYL ALCOHOL936JST6JCNIACT
POLYSORBATE 806OZP39ZG8HIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CYCLOMETHICONENMQ347994ZIACT
GLYCERINPDC6A3C0OXIACT
IMIDUREAM629807ATLIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
CETYL ACETATE4Q43814HXSIACT
STEARYL ACETATEA8005KSX95IACT
OLEYL ACETATEEU1ETP025CIACT
ACETYLATED LANOLIN ALCOHOLSSNN716810PIACT
SORBITAN TRISTEARATE6LUM696811IACT
METHYLPARABENA2I8C7HI9TIACT
OLEYL ALCOHOL172F2WN8DVIACT
OLIVE OIL6UYK2W1W1EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARYL ALCOHOL2KR89I4H1YIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
ANHYDROUS TRISODIUM CITRATERS7A450LGAIACT

Source Document#

Source XML

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.