MEDIKOii Bio Safe Hand Refreshing

Manufacturer
THERANOTICS CO.,LTD. | BIO-FD&C. Co., Ltd.
Effective date
2020-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:39

Label at a glance#

ProductMEDIKOii Bio Safe Hand Refreshing
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

• Place enough product on hands to cover all surfaces. Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ALCOHOL 62% v/v

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Ecklonia Cava Extract, Sophora Flavescens Extract, Centaurea Cyanus Flower Extract, Borago Officinalis Extract, Lavandula Angustifolia (Lavender) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Sclarea (Clary) Extract, Hyacinthus Orientalis (Hyacinth) Extract, Carbomer, Butylene Glycol, Tromethamine, 1,2-Hexanediol, Fragrance

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

WARNINGS

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame
--------------------------------------------------------------------------------------------------------
Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
--------------------------------------------------------------------------------------------------------
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions

DOSAGE & ADMINISTRATION SECTION

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72695-0014-12023-01-30C16284748780-1f386c649-b390-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72695-0014-1MEDIKOii Bio Safe Hand Refreshing100 mL in 1 BOTTLE, PUMPGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72695-0014MEDIKOII BIO SAFE HAND REFRESHING (ALCOHOL) GEL [THERANOTICS CO.,LTD.]1Legacy NDC, 1 package rows20200615_5bb85505-d60c-4c59-ae7a-cc6ebefd8ed4.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72695-001472695-0014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
3f08565a-ece9-46e1-ae8a-1e87419431255bb85505-d60c-4c59-ae7a-cc6ebefd8ed42020-06-15WarningsExact identifier
spl id: 3f08565a-ece9-46e1-ae8a-1e8741943125
spl set id: 5bb85505-d60c-4c59-ae7a-cc6ebefd8ed4

Reported adverse events (FAERS/openFDA)#

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