FDA.reportPublic FDA data

LICE ICE

Manufacturer
NATURALRX LLC | DIVERSIFIED MANUFACTURING CORP
Effective date
2020-03-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:12:49

Label at a glance#

ProductLICE ICE COLOR-FREE
Active ingredientAZADIRACHTA INDICA SEED OIL, TEA TREE OIL
Label structure8 sections

Indications and uses

TREATS HEAD LICE

Dosage and administration

TREATMENT: APPLY LICE ICE GEL GENEROUSLY TO DRY HAIR. MASSAGE WELL DOWN INTO SCALP AND ROOTS, MAKING SURE TO GET ALL THE HAIR ENCASSED IN THE GEL. ALLOW LICE ICE TO AIR DRY COMPLETELY. LEAVE ON 12 TO 15 HOURS. DO NOT COVER THE HAIR. IF PROPERLY APPLIED, ALL LICE AND EGGS WILL BE ENTIRELY ENCASED IN A HARDENED GEL, MAKING IT IMPOSSIBLE FOR LICE TO FEED, LAY EGGS, OR FOR EGGS TO HATCH. VIGOROUSLY SHAMPOO WITH REGULA...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

NEEM OIL.....0.937 X

TEA TREE OIL.....0.937 X

PURPOSE

OTC - PURPOSE SECTION

LICE TREATMENT

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

USES

INDICATIONS & USAGE SECTION

TREATS HEAD LICE

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

TREATMENT: APPLY LICE ICE GEL GENEROUSLY TO DRY HAIR. MASSAGE WELL DOWN INTO SCALP AND ROOTS, MAKING SURE TO GET ALL THE HAIR ENCASSED IN THE GEL. ALLOW LICE ICE TO AIR DRY COMPLETELY. LEAVE ON 12 TO 15 HOURS. DO NOT COVER THE HAIR. IF PROPERLY APPLIED, ALL LICE AND EGGS WILL BE ENTIRELY ENCASED IN A HARDENED GEL, MAKING IT IMPOSSIBLE FOR LICE TO FEED, LAY EGGS, OR FOR EGGS TO HATCH. VIGOROUSLY SHAMPOO WITH REGULAR SHAMPOO, RINSE WELL. DRY HAIR. THOROUGHLY INSPECT HAIR AND SCALP, REAPPLY IF NECESSARY.

PREVENTATIVE:

USE LICE INE IN PLACE OF DAILY STYLING GEL ON WET OR DRY HAR OR DILUTE LICE ICE GEL 1:4 IN WATER AND APPLY TO WET OR DRY HAIR AND SCALP AS A SPRAY. REINFESTATION IS LIKELY IF THE LIVING ENVIRONMENT HAS NOT BEEN CLEANED. PLEASE VISIT WWW.LICEICE.COM FOR MORE INFO.

INGREDIENTS:

INACTIVE INGREDIENT SECTION

PURIFIED WATER, SD ALCOHOL, PVP/VA COPOLYMER, POLYQUATERNIUM 11, TRAGACANTH GUM, DIMETHICONE COPOLYOL, CARBOMER 940, TRIETHANOLAMINE, EMPIRE ORGANICS SPECIAL BLEND OF NEEM, TEA TREE, LEMON, LAVENDER, THYME AND ROSEMARY ESSENTIAL OILS, FD&C BLUE NO. 1, FRAGRANCE, BENZOPHENONE 4.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lice Ice CF_Label_4ozLice Ice CF_Label_4oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69170-103-142022-01-28C16284748780-19d75b9d0-d7f5-f424-e053-dadaa90a57ceNATURALRX - ICE 'EM ALL - COLOR-FREE
69170-103-182022-01-28C16284748780-19d75b9d0-d7f5-f424-e053-dadaa90a57ceNATURALRX - ICE 'EM ALL - COLOR-FREE
69170-103-142020-03-23C16284748780-19d75b9d0-d7f5-f424-e053-dadaa90a57ceNATURALRX - ICE 'EM ALL - COLOR-FREE
69170-103-182020-03-23C16284748780-19d75b9d0-d7f5-f424-e053-dadaa90a57ceNATURALRX - ICE 'EM ALL - COLOR-FREE
69170-103-142020-01-31C16284748780-19d75b9d0-d7f5-f424-e053-dadaa90a57ceNATURALRX - ICE 'EM ALL - COLOR-FREE
69170-103-182020-01-31C16284748780-19d75b9d0-d7f5-f424-e053-dadaa90a57ceNATURALRX - ICE 'EM ALL - COLOR-FREE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69170-103-14LICE ICECOLOR-FREE118 mL in 1 TUBEGEL1183
69170-103-18LICE ICECOLOR-FREE236 mL in 1 TUBEGEL2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69170-103LICE ICE COLOR-FREE (NEEM, TEA TREE) GEL [NATURALRX LLC]3Legacy NDC, 2 package rows20200327_bf480099-8c34-48c7-a397-4408461254fc.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69170-10369170-103-14, 69170-103-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TACTIB
TEA TREE OILVIF565UC2GACTIB
LEMON OILI9GRO824LLIACT
LAVENDER OILZBP1YXW0H8IACT
THYME OIL2UK410MY6BIACT
ROSEMARY OIL8LGU7VM393IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
COPOVIDONE K25-31D9C330MD8BIACT
POLYQUATERNIUM-11 (1000000 MW)0B44BS5IJSIACT
TRAGACANTH2944357O2OIACT
DIMETHICONE92RU3N3Y1OIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
SULISOBENZONE1W6L629B4KIACT

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
82c15dca-a4b4-4102-b352-bb78415cf1abbf480099-8c34-48c7-a397-4408461254fc2015-12-31WarningsExact identifier
spl set id: bf480099-8c34-48c7-a397-4408461254fc

Reported adverse events (FAERS/openFDA)#

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