FDA.reportPublic FDA data

MEDIBLUE

Manufacturer
Multibio Co., Ltd
Effective date
2022-02-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:20

Label at a glance#

ProductMEDIBLUE
Active ingredientHYPOCHLOROUS ACID
Label structure11 sections

Indications and uses

Multi purpose sterilization, disinfection

Dosage and administration

Spray the sterilizing object in a wide range Please supervise when using the product by children, the elderly, the disabled, etc.

Storage and handling

Read the directions and warnings before use If exposed to the air, sterilization may be reduced due to water-soluble, so keep the container sealed. Avoid freezing and excessive heat above 40 degree C (104 degree F) 40C(104F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hypochlorous acid 0.005%

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

USES

DOSAGE & ADMINISTRATION SECTION

Multi purpose sterilization, disinfection

WARNINGS

WARNINGS SECTION

For external use only

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

Keep out of eyes, in case of contact with eyes, flush thoroughly with water

Avoid contact with broken skin

Do not inhale or ingest

WHEN USING THIS PRODUCT

OTC - ASK DOCTOR SECTION

Stop immediately and consult a doctor it you experience skin imitation or rash develops

WHEN USING THIS PRODUCT

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. if swallowed, get medical help or contact a posion control center right away.

DIRECTIONS

INDICATIONS & USAGE SECTION

Spray the sterilizing object in a wide range

Please supervise when using the product by children, the elderly, the disabled, etc.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Read the directions and warnings before use

If exposed to the air, sterilization may be reduced due to water-soluble, so keep the container sealed.

Avoid freezing and excessive heat above 40 degree C (104 degree F) 40C(104F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500ml NDC: 76847-302-01 Label500ml NDC: 76847-302-01 Label

4000ml NDC: 76847-302-02 Label4000ml NDC: 76847-302-02 Label

20000ml NDC: 76847-302-03 Label20000ml NDC: 76847-302-03 Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76847-302-012023-07-28C16284748780-1d6a99b39-f8e9-a426-e053-dadaa90af4c276847-302 Mediblue
76847-302-022023-07-28C16284748780-1d6a99b39-f8e9-a426-e053-dadaa90af4c276847-302 Mediblue
76847-302-032023-07-28C16284748780-1d6a99b39-f8e9-a426-e053-dadaa90af4c276847-302 Mediblue
76847-302-012022-02-18C16284748780-1d6a99b39-f8e9-a426-e053-dadaa90af4c276847-302 Mediblue
76847-302-022022-02-18C16284748780-1d6a99b39-f8e9-a426-e053-dadaa90af4c276847-302 Mediblue
76847-302-032022-02-18C16284748780-1d6a99b39-f8e9-a426-e053-dadaa90af4c276847-302 Mediblue
76847-302-012022-01-28C16284748780-1d6a99b39-f8e9-a426-e053-dadaa90af4c276847-302 Mediblue
76847-302-022022-01-28C16284748780-1d6a99b39-f8e9-a426-e053-dadaa90af4c276847-302 Mediblue
76847-302-032022-01-28C16284748780-1d6a99b39-f8e9-a426-e053-dadaa90af4c276847-302 Mediblue

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76847-302-01MEDIBLUE500 mL in 1 BOTTLE, SPRAYLIQUID5002
76847-302-02MEDIBLUE4000 mL in 1 BOTTLELIQUID40002
76847-302-03MEDIBLUE20000 mL in 1 BOTTLELIQUID200002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76847-302MEDIBLUE (HYPOCHLOROUS ACID) LIQUID [MULTIBIO CO., LTD]2Legacy NDC, 3 package rows20220219_aba9ffa7-b70e-5229-e053-2a95a90a5c92.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76847-30276847-302-01, 76847-302-02, 76847-302-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPOCHLOROUS ACID712K4CDC10ACTIB
WATER059QF0KO0RIACT

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
d8546fb3-4f2f-be76-e053-2a95a90a79ebaba9ffa7-b70e-5229-e053-2a95a90a5c922022-02-18WarningsExact identifier
spl id: d8546fb3-4f2f-be76-e053-2a95a90a79eb
spl set id: aba9ffa7-b70e-5229-e053-2a95a90a5c92

Reported adverse events (FAERS/openFDA)#

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