Label: XOXO HAND DISINFECTANT WIPES- hy-iq water cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 11, 2021

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  • Active Ingredient

    Hydrogen Cation .77%

  • Purpose

    Antiseptic

  • Uses

    For hand sanitizing to decrease bacteria on the surface of the skin.

  • Warnings

    For external use only. Do not use if you are allergic to any of the ingredients. Stop using if a rash develops and ask a doctor right away.

  • Keep Out of Reach of Children

    Keep Out of Reach of Children

  • Directions

    Remove top of canister and pull off lid. Thread wipe through the dispenser lid and tear at perforated line in wipe. To maintain moisture, securely close lid and flap.

  • Other Safety Information

    Store under 110º F (43º C)

  • Inactive Ingredient

    Water, Urea

  • XOXO HAND DISINFECTANT WIPES

    XOXOSkin Label 5.75x2 091021 30 count-01XOXO HAND DISINFECTANT WIPES

  • INGREDIENTS AND APPEARANCE
    XOXO HAND DISINFECTANT WIPES 
    hy-iq water cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76701-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN CATION (UNII: 5046UKT60S) (HYDROGEN CATION - UNII:5046UKT60S) HYDROGEN CATION10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 940 mg  in 1 mL
    UREA (UNII: 8W8T17847W) 50 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76701-402-3059.147 mL in 1 CANISTER; Type 0: Not a Combination Product09/11/2021
    2NDC:76701-402-60118.294 mL in 1 CANISTER; Type 0: Not a Combination Product09/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/11/2021
    Labeler - Hand Sanitizer LLC (117473019)
    Registrant - Hand Sanitizer LLC (117473019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hand Sanitizer LLC117473019manufacture(76701-402) , label(76701-402) , pack(76701-402)