Label: ALSOFT W 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 November 12, 2020

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  • Active ingredient

    Alcohol 72.1 w/w

  • Purpose

    Hand Sanitizer

  • Uses

    • sanitizes hands to help reduce bacteria that potentially can cause disease
    • helps to prevent cross-contamination
    • recommended for repeated use
    • helps pevent drying of skin
  • Warnings

    • For external use only
    • Flammable, keep away from fire or flame

    When using this product

    • do not use in or near eyes
    • use in a well-ventilated area

    Stop use and consult a doctor if irritation or redness develop.

    Keep out of reach of children.

    If swallowed, seek medical attention or contact Poison Control Center immediately.

  • Directions

    • wet hands thoroughly with product, covering entire surface of hands, especially the fingernails and cuticles
    • rub hands together until dry
  • Other information

    store in a cool, dry place below 104 F (40 C)

  • Inactive ingredients

    Carbomer, Glycerin, Glyceryl Caprate, Isopropyl Myristate, Tocopherol Acetate, Triethanolamine, Water

  • Questions?

    Contact Best Sanitizers at 888-225-3267 Mon-Fri 9 am - 4 pm PST

  • PRINCIPAL DISPLAY PANEL

    Alsoft W

    hand sanitizer gel

    72.1%

    Ethyl Alcohol

    Net Contents: 16.9 fl oz (500 mL)

    container labelW

  • INGREDIENTS AND APPEARANCE
    ALSOFT W HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59900-351
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL78.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERYL CAPRATE (UNII: 197M6VFC1W)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59900-351-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/30/2020
    Labeler - Best Sanitizers, Inc (957473614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc.627278224manufacture(59900-351)
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