Label: GENRX ANTI-BACTERIAL GEL- alcohol liquid

  • NDC Code(s): 59088-299-08, 59088-299-31, 59088-299-39, 59088-299-48
  • Packager: PureTek Corporation
  • 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 August 18, 2022

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  • Active Ingredient

    Alcohol 62% (v/v)

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    Flammable. Keep away from fire or flame.

  • When using this product

    do not use in or near eyes. In case of contact, rinse eyes throughly with water

  • Stop use and ask a doctor if

    If irritation or rash appears and lasts.

  • Keep out of reach of children

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

  • Directions

    ■ Dispense and rub onto hands until dry. Do not rinse off.

    ■ Children under 6 years of age should use this product under supervision.

  • Other information

    ■ Do not store above 110°F (43°C)

  • Inactive ingredients

    Aloe Barbadensis (aloe vera) Leaf Juice, Aminomethyl Propanol, Butyrospermum Parkii (Shea) Butter, Carbomer, Glycerin, Isopropyl Myristate, Water (Aqua)

  • GenRx Hand Sanitizing Gel (24 fl oz)

    Label

  • INGREDIENTS AND APPEARANCE
    GENRX ANTI-BACTERIAL GEL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-299
    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
    SHEA BUTTER (UNII: K49155WL9Y)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-299-48710 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/18/202005/11/2020
    2NDC:59088-299-08118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/18/2020
    3NDC:59088-299-31500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/18/2020
    4NDC:59088-299-39710 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/18/2020
    Labeler - PureTek Corporation (785961046)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046manufacture(59088-299)
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