FDA.reportPublic FDA data

16BKOUTY Lice Treatment

Manufacturer
Shenzhen Graceful Cosmetics Co., Ltd
Effective date
2024-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:05

Label at a glance#

Product16BKOUTY Lice Treatment
Active ingredientSTEMONA SESSILIFOLIA ROOT
Label structure7 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

After washing your hair, spray an appropriate amount of liquid on the roots of your hair to moisten it

WARNINGS SECTION

1. Discontinue use for individuals with skin allergies.

2. Do not use this product when its characteristics have changed.

3. Children must use it under adult supervision.

4. Please keep this product out of reach of children.

INACTIVE INGREDIENT SECTION

BENZYL BENZOATE、CHLORHEXIDINE ACETATE、WATER 、ALCOHOL、SOPHORA FLAVESCENS ROOT、DIBUTYL PHTHALATE 、CNIDIUM MONNIERI FRUIT OIL

INDICATIONS & USAGE SECTION

STEMONA JAPONICA WHOLE

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

. Please keep this product out of reach of children.

OTC - PURPOSE SECTION

Spray on the roots of hair

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1184422-102-01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84422-102-0116BKOUTY Lice Treatment120 mL in 1 BOTTLELIQUID1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84422-10216BKOUTY LICE TREATMENT LIQUID [SHENZHEN GRACEFUL COSMETICS CO., LTD]11 package rows20240812_1eeb073c-320c-c570-e063-6294a90ab79f.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84422-10284422-102-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL BENZOATEN863NB338GIACT
CHLORHEXIDINE ACETATE5908ZUF22YIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
DIBUTYL PHTHALATE2286E5R2KEIACT
CNIDIUM MONNIERI FRUIT OILJK0MS9P8YLIACT
STEMONA SESSILIFOLIA ROOTEKG8030U4NACTIB

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
1eeb073c-320d-c570-e063-6294a90ab79f1eeb073c-320c-c570-e063-6294a90ab79f2024-08-05WarningsExact identifier
spl id: 1eeb073c-320d-c570-e063-6294a90ab79f
spl set id: 1eeb073c-320c-c570-e063-6294a90ab79f

Reported adverse events (FAERS/openFDA)#

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