FDA.reportPublic FDA data

STE-MEDI

Manufacturer
ELLAMUSE KOREA
Effective date
2020-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:11

Label at a glance#

ProductSTE-MEDI
Active ingredientHYPOCHLOROUS ACID, TEA TREE OIL, CHAMAECYPARIS OBTUSA WOOD OIL, LAVENDER OIL, ALCOHOL
Label structure11 sections

Indications and uses

Hand Sanitizer to reduce skin bacteria and viruses on the skin

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping For children under 6, use only adult supervision Not recommended for infants

Storage and handling

Do not store above 105F May discolor certain fabrics

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hypochlorous acid water (HOCL) 90%

Ethyl Alcohol 5%

Tea tree oil 0.2%, Chamaecyparis obtusa oil 0.15%, Lavender oil 0.15%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

DOSAGE & ADMINISTRATION SECTION

Hand Sanitizer to reduce skin bacteria and viruses on the skin

Warnings

WARNINGS SECTION

External use only: hand

When disinfecting the object, spray it and wipe it with a dry cotton cloth.

When using this product

OTC - WHEN USING SECTION

Avoid the eyes. If it gets into your eyes, rinse them thoroughly with water.

Do not inhale or ingest.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

Irritation or redness develops

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical attention.

Directions

INDICATIONS & USAGE SECTION

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only adult supervision

Not recommended for infants

Other information

STORAGE AND HANDLING SECTION

Do not store above 105F

May discolor certain fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hyaluronic acid, chitosan, allantoin, witch hazel extract

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50ml NDC: 77599-202-01 Label50ml NDC: 77599-202-01 Label

100ml NDC: 77599-202-02 Label100ml NDC: 77599-202-02 Label

200ml NDC: 77599-202-03 Label200ml NDC: 77599-202-03 Label

300ml NDC: 77599-202-04 Label300ml NDC: 77599-202-04 Label

500ml NDC: 77599-202-05 Label500ml NDC: 77599-202-05 Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77599-202-012022-01-28C16284748780-1d6a99b39-8210-a426-e053-dadaa90af4c277599-202
77599-202-022022-01-28C16284748780-1d6a99b39-8210-a426-e053-dadaa90af4c277599-202
77599-202-032022-01-28C16284748780-1d6a99b39-8210-a426-e053-dadaa90af4c277599-202
77599-202-042022-01-28C16284748780-1d6a99b39-8210-a426-e053-dadaa90af4c277599-202
77599-202-052022-01-28C16284748780-1d6a99b39-8210-a426-e053-dadaa90af4c277599-202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77599-202-01STE-MEDI50 mL in 1 BOTTLE, SPRAYLIQUID501
77599-202-02STE-MEDI100 mL in 1 BOTTLE, SPRAYLIQUID1001
77599-202-03STE-MEDI200 mL in 1 BOTTLE, SPRAYLIQUID2001
77599-202-04STE-MEDI300 mL in 1 BOTTLE, SPRAYLIQUID3001
77599-202-05STE-MEDI500 mL in 1 BOTTLE, SPRAYLIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77599-202STE-MEDI (HYPOCHLOROUS ACID) LIQUID [ELLAMUSE KOREA]1Legacy NDC, 5 package rows20200605_a73ec911-55b1-9b80-e053-2a95a90a68e4.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77599-20277599-202-01, 77599-202-02, 77599-202-03, 77599-202-04, 77599-202-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPOCHLOROUS ACID712K4CDC10ACTIB
TEA TREE OILVIF565UC2GACTIB
CHAMAECYPARIS OBTUSA WOOD OILP2OMP71Y62ACTIB
LAVENDER OILZBP1YXW0H8ACTIB
ALCOHOL3K9958V90MACTIB
HYALURONIC ACIDS270N0TRQYIACT
POLIGLUSAM HYDROCHLORIDEF351U03I47IACT
ALLANTOIN344S277G0ZIACT
WITCH HAZEL101I4J0U34IACT

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
a73ec911-55b2-9b80-e053-2a95a90a68e4a73ec911-55b1-9b80-e053-2a95a90a68e42020-06-04WarningsExact identifier
spl id: a73ec911-55b2-9b80-e053-2a95a90a68e4
spl set id: a73ec911-55b1-9b80-e053-2a95a90a68e4

Reported adverse events (FAERS/openFDA)#

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