Label: PROBLEND HAND SANITIZER GEL- ethanol gel

  • NDC Code(s): 76250-140-01, 76250-140-02, 76250-140-03
  • Packager: Seatex, 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 January 26, 2023

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  • Drug Facts

    Active Ingredient Purpose

    Ethanol 70% v/v....... Antiseptic

  • When using this product

    Avoid contact with eyes. In case of eye contact, flush eyes with water.

  • Keep out of reach of children

    If swallowed, get medical help or cantact a Poison Control Center right away.

  • Inactive Ingredients

    Water, Glycerin, Polyacrylidc Acid, Fragrance, Dye.

  • Purpose Section

    Antiseptic

  • Stop Use Section

    Stop use and ask a doctor if irritation or redness develops and conditions persist for more than 72 hours.

  • Indications & Usage Section

    Uses: For hand sanitizing to decrease bacteria on the skin.

  • Dosage and Administation Section

    Directions

    Place enough product in your palm to thoroughly cover hands. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

  • Warnings

    For external use only. Flammable. Keep away from fire or flame.

  • Label

    PB0027139 Hand Sanitizer 1 Gal

  • Problend Hand Sanitizer Gel Label-Front

    PB0027139-Hand Sanitizer-1.25-L-FRONT-LABEL

  • Problend Hand Sanitizer Gel Label-Back

    PB0027139-Hand-Sanitizer-1.25-L-BACK-LABEL

  • INGREDIENTS AND APPEARANCE
    PROBLEND HAND SANITIZER GEL 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76250-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 70 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76250-140-011249000 mL in 1 CONTAINER; Type 0: Not a Combination Product01/25/2023
    2NDC:76250-140-02125000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product01/25/2023
    3NDC:76250-140-0318900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/25/2023
    Labeler - Seatex, LLC (026647404)
    Registrant - Seatex, LLC (026647404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seatex, LLC026647404label(76250-140) , manufacture(76250-140) , pack(76250-140)
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