Label: BLOSSOM ANTIBACTERIAL HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 9, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Ethyl Alcohol 62%

  • Purpose

    Antibacterial

  • Uses

    For hand washing to decrease bacteria on skin.

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    When using this product

    Keep out of eyes. In case of contact with eyes rinse with water.

    Stop use and ask doctor if irritation and redness develops and persists.

    Keep out of reach of children. If swallowed, get medical help promptly and contact Poison Control.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other Information

    Store under 105° F

  • Inactive Ingredients

    Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

  • Questions or Comment?

    www.blossombeauty.com
    (818) 361-5200

  • SPL UNCLASSIFIED SECTION

    Distributed By: Fantasy Files, LLC
    San Fernando, CA 91340

  • PRINCIPAL DISPLAY PANEL - 58 mL Bottle Label

    BLOSSOM®

    ANTIBACTERIAL
    HAND
    SANITIZER

    2 fl. oz./58 mL

    PRINCIPAL DISPLAY PANEL - 58 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BLOSSOM ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80583-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80583-110-5858 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E09/01/2020
    Labeler - FANTASY FILES, LLC (603581690)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG AYAN BIOTECH CO., LTD.544377996MANUFACTURE(80583-110)
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