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

  • Category: HUMAN OTC DRUG LABEL

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 September 9, 2020

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  • ACTIVE INGREDIENT

    alcohol

  • INACTIVE INGREDIENT

    Water
    Glycerin
    Aloe Barbadensis Leaf Extract
    Camellia Sinensis Leaf Extract
    Chamomilla Recutita (Matricaria) 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

    pull ouy wipes and sanitize hands when necessary

  • 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 TISSUE (ETHANOL) 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74773-0028
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74773-0028-1120 g in 1 BOTTLE; 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
    C&TECH CORPORATION688204698manufacture(74773-0028)
    Establishment
    NameAddressID/FEIBusiness Operations
    THESKINFACTORY Co., Ltd.694804099label(74773-0028)
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