IBREA MICRO SILVER HAND WITH PURE SILVER- alcohol, silver gel

iBrea Micro Silver Hand with Pure Silver by

Drug Labeling and Warnings

iBrea Micro Silver Hand with Pure Silver by is a Otc medication manufactured, distributed, or labeled by IBREA GLOBAL CO.,LTD., Mi-face Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ALCOHOL 38% v/v
SILVER 0.10%

INACTIVE INGREDIENTS

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

PURPOSE

ANTISEPTIC, ANTIMICROBIAL, ANTI-BACTERIAL, ANTI-VIRUS

WARNINGS

For external use only.
Flammable. Keep away from heat or flame
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Do not use
In children less than 2 months of age
Avoid contact with broken skin
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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.
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Stop use and ask a doctor if skin irritation occurs and consult a doctor immediately.

KEEP OUT OF REACH OF CHILDREN

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

Uses

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

Directions

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 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

INGREDIENTS AND APPEARANCE

IBREA MICRO SILVER HAND WITH PURE SILVER 
alcohol, silver gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78030-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	19 mL  in 50 mL
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)	SILVER	0.05 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78030-010-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2020

Labeler - IBREA GLOBAL CO.,LTD. (694812182)

Registrant - IBREA GLOBAL CO.,LTD. (694812182)

Establishment
Name	Address	ID/FEI	Business Operations
Mi-face Co., Ltd		694820628	manufacture(78030-010)