FDA.reportPublic FDA data

ImK hand sanitizer

Manufacturer
Biopontis inc | K.Boeun Pharmaceutical Co.,Ltd.
Effective date
2020-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:08

Label at a glance#

ProductImK hand sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Put as needed in your palms and rub your hands together briskly until dry Children under 6 years of age should be supervised when using this product

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. active ingreactive ingre Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

PurposePurposeAntiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand sanitized to help reduce bacteria on the skin UseUse

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts Do not useDo not use

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put as needed in your palms and rub your hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product dosage admindosage admin

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water(aqua), Glycerin, Aloe Vera Leaf, Tromethamine, Carbomer inactive ingredientsinactive ingredients

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 ml NDC:73856-535-18 LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73856-535-182022-01-28C16284748780-1d6a99b39-8e48-a426-e053-dadaa90af4c2a84a5956-5e7b-2ab9-e053-2a95a90ad9ff

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73856-535-18ImK hand sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73856-535IMK HAND SANITIZER (ETHYL ALCOHOL) GEL [BIOPONTIS INC]1Legacy NDC, 1 package rows20200618_a84a5956-5e7b-2ab9-e053-2a95a90ad9ff.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73856-53573856-535-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROMETHAMINE023C2WHX2VIACT
ALOEV5VD430YW9IACT

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
a84a68aa-8ee3-05a5-e053-2a95a90a27cea84a5956-5e7b-2ab9-e053-2a95a90ad9ff2020-06-17WarningsExact identifier
spl id: a84a68aa-8ee3-05a5-e053-2a95a90a27ce
spl set id: a84a5956-5e7b-2ab9-e053-2a95a90ad9ff

Reported adverse events (FAERS/openFDA)#

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