FDA.reportPublic FDA data

ImK hand sanitizer

Manufacturer
Biopontis inc | Dermasnatural Co., Ltd.
Effective date
2020-05-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:14:07

Label at a glance#

ProductImK hand sanitizer
Active ingredientALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

active ingredientactive ingredient

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

keep out of reach of childrenkeep out of reach of children

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts

stop usestop use

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

when usingwhen using

DOSAGE & ADMINISTRATION SECTION

DIrections

Spray on palm, rub hands together

children under 6 years of age should be supervised when using this product

dosage and admindosage and admin

WARNINGS SECTION

Warning

Flammable. Keep away from fire or flame.

For external use only.

warningswarnings

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water(aqua), Butylene Glycol, Glycerin, Camellia Sinensis Leaf Extract, Phenoxyethanol, Ethylhexylglycerin inactive ingredientsinactive ingredients

INDICATIONS & USAGE SECTION

Use

Hand sanitized to help reduce bacteria on the skin

indication usageindication usage

OTC - PURPOSE SECTION

Use

Hand sanitized to help reduce bacteria on the skin

purposepurpose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package label

PackagePackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041849ethanol 70 % Topical SprayPSN2
1041849ethanol 0.7 ML/ML Topical SpraySCD2
1041849ethanol 70 % Topical SpraySY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809553260914GTIN-13: 8809553260914
EAN-13: 8809553260914
GTIN storage (14 digits): 08809553260914		label-final2.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73856-545-112021-07-23C16284748780-1c7ccaba7-1ed5-fd44-e053-dadaa90aa01ba18a3e56-bb9b-1aba-e053-2995a90a730e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73856-545-11ImK hand sanitizer50 mL in 1 BOTTLESPRAY502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73856-545IMK HAND SANITIZER (ETHYL ALCHOCOL) SPRAY [BIOPONTIS INC]2Legacy NDC, 1 package rows20200522_a18a3e56-bb9b-1aba-e053-2995a90a730e.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73856-54573856-545-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT

Source Document#

Source XML · Source PDF

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
a62d2015-4181-7ef6-e053-2a95a90ae23ea18a3e56-bb9b-1aba-e053-2995a90a730e2020-05-22WarningsExact identifier
spl id: a62d2015-4181-7ef6-e053-2a95a90ae23e
spl set id: a18a3e56-bb9b-1aba-e053-2995a90a730e

Reported adverse events (FAERS/openFDA)#

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