Label: HAND SANITIZER TOWELETTE cloth

  • 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 27, 2020

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  • Active Ingredient(s)

    Benzalkonium chloride 0.13%

  • Purpose

    Antimicrobial

  • Use

    To help reduce microbes on the skin.

  • Warnings

    • For external use only.
    • Do not dispose of wipes in flush toilets.
    • Flammable: Keep away from fire or flame.
  • WHEN USING

    When using this product: avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop using and ask a doctor if: irritation or redness develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: in case of accidental ingestion, get medical help or contact a poison control center immediately.

  • Directions

    • No rinsing required, Discard after use.
    • Apply to hands or skin.

  • Other information

    • For external use only.
    • Do not dispose of wipes in flush toilets.
    • Store below 110° F (43°C)
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water(Aqua), Methylisothiazolinone, lodopropynyl Butylcarbamate, Glycerol, disodium EDTA, AloeBarbadensisLeafJuice, Tweau, Allantion, RetinylPalmitate, Lanoliue, LsopropylMYRISTATE, Fragrance.

  • Package Label - Principal Display Panel

    1pcs NDC: 42509-022-01 1pcs label

    1pcs NDC: 42509-022-02 1pcs label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER TOWELETTE 
    hand sanitizer towelette cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42509-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
    WATER (UNII: 059QF0KO0R)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42509-022-011 in 1 PACKET07/27/2020
    13.915 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:42509-022-021 in 1 PACKET07/27/2020
    23.915 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/27/2020
    Labeler - WESSCO International (118553619)
    Establishment
    NameAddressID/FEIBusiness Operations
    WESSCO International118553619label(42509-022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang iColor Biotech Co., Ltd554528308manufacture(42509-022)
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