Label: HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 April 16, 2020

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  • Drug Facts

  • Active Ingredient

    Alcohol 60%

    Purpose:

    Antiseptic

  • Use:

    Decreases bacteria on hands

  • Warnings:

    For external use only.

  • Warnings: (additional)

    Flammable-Keep product away from fire or flame.

    When using this product

    avoid contact with eyes; in case of contact, flush eyes with water.

    Stop use & ask a doctor if

    irritation or redness develops and persists.

    Keep out or reach of children.

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

  • Directions:

    Wet hands thoroughly with product and allow to dry.

  • Inactive Ingredients:

    Water(Aqua), Glycerin, Carbomer, Triethanolamine, Siliver, Fragrance(Parfum)

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74711-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.6 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SILVER (UNII: 3M4G523W1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74711-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/15/2020
    Labeler - Natural Blossom (Fujian) Industry & Trade Co., Ltd. (416269409)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Blossom (Fujian) Industry & Trade Co., Ltd.416269409manufacture(74711-001)
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