Label: HAND SANITIZER ALCOHOL BASED FORMULA- 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 July 31, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin that could cause disease
    • 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 or surfaces
  • Inactive Ingredients

    Water, Propylene Glycol, Carbomer, PEG-7 Glyceryl Cocoate , Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance

  • Questions or Comments ?

    1-347-762-7269

  • SPL UNCLASSIFIED SECTION

    DIST. BY SOAPBOX SOAPS LLC
    ALL RIGHTS RESERVED
    WASHINGTON, D.C. 20007

  • PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label

    SOAPBOX®

    HAND
    SANITIZER

    • 70% ALCOHOL •
    BASED FORMULA

    LIGHT CITRUS SCENT

    HELPS REDUCE PATHOGENIC
    GERMS ON HANDS

    WITH MOISTURIZERS
    ALOE & VITAMIN E

    NET 1 GAL (3.78 L)

    PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER   ALCOHOL BASED FORMULA
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75115-128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Propylene Glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    PEG-7 Glyceryl Cocoate (UNII: VNX7251543)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Aloe vera leaf (UNII: ZY81Z83H0X)  
    AminoMethylPropanol (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75115-128-013780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E08/03/2020
    Labeler - Soapbox Soaps, LLC (034861706)
    Registrant - BMC 1092, Inc. dba Solo Laboratories, Inc. (078831987)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMC 1092, Inc. dba Solo Laboratories, Inc.078831987MANUFACTURE(75115-128) , LABEL(75115-128) , PACK(75115-128)
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