Label: KUNDAL PURE AND SAFE SANITIZING WIPE (ETHANOL)- alcohol liquid

  • 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 October 4, 2020

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  • ACTIVE INGREDIENT

    alcohol

  • INACTIVE INGREDIENT

    Water
    Glycerin
    Camellia Sinensis Leaf Extract

    calendula officinalis flower extract

  • PURPOSE

    hand sanitizing tissue to help reduce bacteria on the skin

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    plae enough product on hands to cover all surfaces, rub hands together until dry

  • WARNINGS

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

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    KUNDAL PURE AND SAFE SANITIZING WIPE (ETHANOL) 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74773-0029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL50.967 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74773-0029-15 g in 1 POUCH; Type 0: Not a Combination Product09/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/09/2020
    Labeler - THESKINFACTORY Co., Ltd. (694804099)
    Registrant - THESKINFACTORY Co., Ltd. (694804099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sauber Co.,Ltd.690395844manufacture(74773-0029)
    Establishment
    NameAddressID/FEIBusiness Operations
    THESKINFACTORY Co., Ltd.694804099label(74773-0029)
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