FDA.reportPublic FDA data

KAEWOON

Manufacturer
RNCARE
Effective date
2021-10-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:42:36

Label at a glance#

ProductKAEWOON
Active ingredientALLANTOIN, GLYCERIN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Glycerin 3%

Allantoin 0.2%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

Body Cleansing

DOSAGE & ADMINISTRATION SECTION

Take an appropriate amount and massage onto scalp/body for about 60 seconds and rinse with water

WARNINGS SECTION

In case of eye contact, immediately rinse with water

Stop use if unusual redness, swelling, soreness or irritation occur

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INACTIVE INGREDIENT SECTION

Cocamide DEA, Oleic Acid, Lauramidopropyl Betaine, PEG-60 Castor Oil, Oryza Sativa (Rice) Bran Extract, Camellia Sinensis Leaf Extract, Shea Butteramidopropyl Betaine, Polysorbate 80, Water, Propylene Glycol, Sodium Cocoamphoacetate, Butylene Glycol, Capryl/Capramidopropyl Betaine, Lecithin, Curcuma Longa (Turmeric) Root Extract, Phaseolus Radiatus Seed Extract, Artemisia Vulgaris Extract, Arctium Lappa Root Extract, Hippophae Rhamnoides Extract, Crataegus Oxyacantha Extract, Rheum Palmatum Root Extract, Bambusa Vulgaris Extract, Eucalyptus Globulus Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Panax Ginseng Root Extract, Propolis Extract, 6-Aminocaproic Acid, Polyquaternium, Disodium EDTA, Black Strap Powder, Hexanediol, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Hydroxyethylcellulose, Menthol, Citric Acid, Frageance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71237-001-022023-01-30C16284748780-1ba0f9c33-54b3-a910-e053-dadaa90a0b8571237-001_V3
71237-001-022021-10-04C16284748780-1ba0f9c33-54b3-a910-e053-dadaa90a0b8571237-001_V3
71237-001-022021-01-29C16284748780-1ba0f9c33-54b3-a910-e053-dadaa90a0b8571237-001_V3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71237-001-01KAEWOON320 mL in 1 BOTTLEGEL3204
71237-001-02KAEWOON1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71237-001KAEWOON (GLYCERIN, ALLANTOIN) GEL [RNCARE]4Legacy NDC, 2 package rows20211005_516b9ebb-ee12-47c2-afc5-24c7094cca25.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71237-00171237-001-01, 71237-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCO DIETHANOLAMIDE92005F972DIACT
OLEIC ACID2UMI9U37CPIACT
LAURAMIDOPROPYL BETAINE23D6XVI233IACT
PEG-60 CASTOR OILVXP26NM2XXIACT
RICE BRANR60QEP13ICIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM COCOAMPHOACETATEW7Q5E87674IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
TURMERIC856YO1Z64FIACT
MUNG BEAN1LIB31N73GIACT
ARTEMISIA VULGARIS ROOT32MP823R8SIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
HIPPOPHAE RHAMNOIDES FRUITAVL0R9111TIACT
CRATAEGUS LAEVIGATA FLOWER85EAT04F4HIACT
RHEUM PALMATUM ROOTG025DAL7CEIACT
BAMBUSA VULGARIS TOPFIW80T6P6VIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
MATRICARIA RECUTITA FLOWERING TOP3VNC7T6Z02IACT
ASIAN GINSENGCUQ3A77YXIIACT
PROPOLIS WAX6Y8XYV2NOFIACT
AMINOCAPROIC ACIDU6F3787206IACT
EDETATE DISODIUM7FLD91C86KIACT
HEXANEDIOLZIA319275IIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
ALLANTOIN344S277G0ZACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXACTIB

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
cd8acdc6-073b-5ca3-e053-2a95a90aaf1f516b9ebb-ee12-47c2-afc5-24c7094cca252021-10-04WarningsExact identifier
spl id: cd8acdc6-073b-5ca3-e053-2a95a90aaf1f
spl set id: 516b9ebb-ee12-47c2-afc5-24c7094cca25

Reported adverse events (FAERS/openFDA)#

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