FDA.reportPublic FDA data

SURE PROTECT HAND SANITIZER

Manufacturer
E-House Korea Holdings International
Effective date
2020-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:30

Label at a glance#

ProductSURE PROTECT HAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Spray directly on hands and rub in thoroughly. For children under 6, use adult supervision. Not recommended for infant.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol Denat. 70 %v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • Helps reduce bacteria on the skin.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire, sparks and sources of ignition. Do not store above 104°F/40°C

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water. 
  • Avoid contact with broken skin.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray directly on hands and rub in thoroughly. For children under 6, use
  • adult supervision. Not recommended for infant.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Butylene Glycol, Camellia Sinensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Extract, Centella Asiatica Extract, Portulaca Oleracea Extract, Anthemis Nobilis Flower Extract , Phenoxyethanol, Ethylhexylglycerin

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50387-002-012021-07-23C16284748780-1c7ccaba7-26b8-fd44-e053-dadaa90aa01b6bf51ad9-81bb-45df-b299-a084b2199214

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50387-002-01SURE PROTECT HAND SANITIZER50 mL in 1 BOTTLE, PLASTICLIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50387-002SURE PROTECT HAND SANITIZER (ALCOHOL) LIQUID [E-HOUSE KOREA HOLDINGS INTERNATIONAL]1Legacy NDC, 1 package rows20200917_6bf51ad9-81bb-45df-b299-a084b2199214.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50387-00250387-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
CENTELLA ASIATICA WHOLE7M867G6T1UIACT
PURSLANEM6S840WXG5IACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
5fe7bdf7-e45b-4b16-a56c-3591de2c82746bf51ad9-81bb-45df-b299-a084b21992142020-09-16WarningsExact identifier
spl id: 5fe7bdf7-e45b-4b16-a56c-3591de2c8274
spl set id: 6bf51ad9-81bb-45df-b299-a084b2199214

Reported adverse events (FAERS/openFDA)#

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