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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 21, 2020

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  • ACTIVE INGREDIENTS

    ALCOHOL 63% v/v
    SILVER 0.10%

  • INACTIVE INGREDIENTS

    WATER, GLYCERIN, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE

  • PURPOSE

    ANTISEPTIC, ANTIMICROBIAL, ANTI-BACTERIAL, ANTI-VIRUS

  • WARNINGS

    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

    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

    Image of container

  • INGREDIENTS AND APPEARANCE
    IBREA MICRO SILVER HAND WITH PURE SILVER 
    alcohol, silver gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78030-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL31.5 mL  in 50 mL
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER0.05 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78030-020-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2020
    Labeler - IBREA GLOBAL CO.,LTD. (694812182)
    Registrant - IBREA GLOBAL CO.,LTD. (694812182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mi-face Co., Ltd694820628manufacture(78030-020)
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