FDA.reportPublic FDA data

iBrea Micro Silver Hand with Pure Silver

Manufacturer
IBREA GLOBAL CO.,LTD. | Mi-face Co., Ltd
Effective date
2020-05-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:14:07

Label at a glance#

ProductiBrea Micro Silver Hand with Pure Silver
Active ingredientALCOHOL, SILVER
Label structure9 sections

Indications and uses

This rinse-free hand gel moisturizers the hands while cleaning, it also refreshes and reduces bacterial growth through silver ions released from MICROSILVER

Dosage and administration

• Apply liberally as often as needed. • Slight trace of pure silver powder is normal and not harmful. • Please SHAKE WELL before use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ALCOHOL 38% v/v
SILVER 0.10%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, GLYCERIN, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, CAPRYLYL GLYCOL, CARBOMER, ETHYLHEXYLGLYCERIN, SODIUM HYDROXIDE

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC, ANTIMICROBIAL, ANTI-BACTERIAL, ANTI-VIRUS

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
• Avoid contact with broken skin
--------------------------------------------------------------------------------------------------------
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 skin irritation occurs and consult a doctor immediately.

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

This rinse-free hand gel moisturizers the hands while cleaning, it also refreshes and reduces bacterial growth through silver ions released from MICROSILVER

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally as often as needed.
• Slight trace of pure silver powder is normal and not harmful.
• Please SHAKE WELL before use.

Other information

OTHER SAFETY INFORMATION

Other information
• Store in a cool, dry place, keep away from direct sunlight.
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of containerImage of container

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78030-010-012022-07-29C16284748780-1e4f33bdf-a506-d8a0-e053-dadaa90a6e4e9c39235f-3f35-4c35-945d-343cecd94b3d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78030-010-01iBrea Micro Silver Hand with Pure Silver50 mL in 1 CONTAINERGEL502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78030-010IBREA MICRO SILVER HAND WITH PURE SILVER (ALCOHOL, SILVER) GEL [IBREA GLOBAL CO.,LTD.]2Legacy NDC, 1 package rows20200522_9c39235f-3f35-4c35-945d-343cecd94b3d.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
78030-01078030-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
SILVER3M4G523W1GACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
fabe3ac5-5500-4d06-b1bb-f68c3361aa619c39235f-3f35-4c35-945d-343cecd94b3d2020-05-21WarningsExact identifier
spl id: fabe3ac5-5500-4d06-b1bb-f68c3361aa61
spl set id: 9c39235f-3f35-4c35-945d-343cecd94b3d

Reported adverse events (FAERS/openFDA)#

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