FDA.reportPublic FDA data

16BKOUTY NALL FUNGUS RENEWAL

Manufacturer
Shenzhen Graceful Cosmetics Co., Ltd
Effective date
2024-07-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:16:08

Label at a glance#

Product16BKOUTY NALL FUNGUS RENEWAL
Active ingredientPHELLODENDRINE, UNDECYLENIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

If you experience any discomfort, please stop using and seek medical attention promptly

CLEANING, DISINFECTING, AND STERILIZATION INSTRUCTIONS

22

DOSAGE & ADMINISTRATION SECTION

【 Instructions 】 Take an appropriate amount of this product and apply it to the surface of the skin.Once in the morning and once in the evening.

INACTIVE INGREDIENT SECTION

123123

INDICATIONS & USAGE SECTION

789789

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children 55

OTC - PURPOSE SECTION

66This product is used for skin antibacterial purposes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84422-101-0116BKOUTY NALL FUNGUS RENEWAL30 mL in 1 BOTTLELIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84422-10116BKOUTY NALL FUNGUS RENEWAL LIQUID [SHENZHEN GRACEFUL COSMETICS CO., LTD]41 package rows20240728_1bb4a876-e1a5-89ad-e063-6394a90abce6.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84422-10184422-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AIACT
CAMPHOR OIL75IZZ8Y727IACT
ACETIC ACIDQ40Q9N063PIACT
SILVER CATION57N7B0K90AIACT
PROTOSTEPHANINE8HEL0402TNIACT
LONICERA CAPRIFOLIUM FLOWER5N1WD9784UIACT
AINSLIAEA FRAGRANS WHOLE5FG998PBC2IACT
PLATYCLADUS ORIENTALIS LEAF32E5V7G32BIACT
PHELLODENDRINEAR68S526RBACTIB
CHLORHEXIDINE ACETATE5908ZUF22YIACT
LEONURINE09Q5W34QDAIACT
GLYCERINPDC6A3C0OXIACT
COMMIPHORA MYRRHA WHOLEUU81N77RI7IACT
BORNEOLM89NIB437XIACT
OLIVE OIL6UYK2W1W1EIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
CROCUS SATIVUS FLOWER00IF91KFKQIACT
IMPATIENS BALSAMINA FLOWER3169PS5TJHIACT
SMILACIN7913T95W7UIACT
PURSLANEM6S840WXG5IACT
CYRTOMIUM FORTUNEI WHOLEKVO7W5ZIG8IACT
EUCALYPTUS SMITHII OILX4023CB3OKIACT
ALOE FEROX LEAF0D145J8EMEIACT
STEPHANIA JAPONICA WHOLE9R6ON4417XIACT
GLEDITSIA SINENSIS THORN26LKE578NYIACT
ISATIDINE51819GRV4UIACT

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
1e3679c1-491e-5a2d-e063-6394a90a4b451bb4a876-e1a5-89ad-e063-6394a90abce62024-07-27WarningsExact identifier
spl id: 1e3679c1-491e-5a2d-e063-6394a90a4b45
spl set id: 1bb4a876-e1a5-89ad-e063-6394a90abce6

Reported adverse events (FAERS/openFDA)#

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