Label: HAND SANITIZER 62% ALCOHOL BASED FORMULA- 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 April 17, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • for hand washing to decrease bacteria on the skin
    • recommended for repeated use
  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    When using this product do not use in or near the eyes.

    In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and rash appears and lasts.

    Keep Out of reach of children. If swallowed get medical help or contact poison control center (1-800-222-1222) right away.

  • Directions

    • Place enough product in your palm to thoroughly cover your hands.
    • Rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other Information

    • store at room temperature
    • may discolor certain fabrics
  • Inactive Ingredients

    Water, Propylene Glycol, Acrylates/C10-3- Alkyl Acrylate Crosspolymer, Peg-60 Almond Glycerides, Aloe Barbadensis Leaf Juice, Triisopropanolamine, Fragrance

  • Questions or Comments ?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DIST. BY SOAPBOX SOAPS LLC | WASHINGTON, D.C. 20007

  • PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

    SOAPBOX®

    HAND
    SANITIZER

    • 62% ALCOHOL •
    BASED FORMULA

    • HELPS REDUCE PATHOGENIC
      GERMS ON HANDS
    • WITH MOISTURIZERS
      & VITAMIN E

    12 FL OZ (354 mL)

    PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER   62% ALCOHOL BASED FORMULA
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75115-772
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75115-772-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E04/20/2020
    Labeler - Soapbox Soaps, LLC (034861706)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMC 1092, Inc. dba Solo Laboratories, Inc.078831987MANUFACTURE(75115-772) , LABEL(75115-772) , PACK(75115-772)
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