Label: GENESIS TODAY HAND SANITIZER- alcohol gel

  • NDC Code(s): 62400-0016-1
  • Packager: United Laboratories Manufacturing, LLC
  • 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 30, 2020

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  • Active ingredients

    Ethyl Alcohol 70.0% v/v

    Purpose

    Anti Microbial

  • Warnings

    Flammable: keep away from excessive heat or open flame.

    For external use only.

    Do not use 

    in or near eyes. In case of eye contact, flush with water. Do not apple to open wounds or damaged skin.  

    Keep out of reach of children.

    Stop use and consult a doctor

    if irritation occurs.

  • Directions

    • Aplly entire packet to palm of hand. Use no water or towels. Rub until hands are completely covered.
  • Inactive ingredients

    Distilled Water, Biopol Plus / Carbomer 940, Aloe Vera Aqueous Extract, Aminomethyl Propane, Rapidgel.

  • Uses

    • Hand sanitizer helps reduce bacteria on the skin could cause disease.
  • Package Labeling:

    Box

  • INGREDIENTS AND APPEARANCE
    GENESIS TODAY HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62400-0016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62400-0016-11000 in 1 BOX07/30/2020
    12.25 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/30/2020
    Labeler - United Laboratories Manufacturing, LLC (807878116)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dibar Nutricional, S. de R.L. de C.V.812786543manufacture(62400-0016) , label(62400-0016) , pack(62400-0016)
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