Label: THE KEEPS ETHANOL 62 PERCENT- alcohol gel

  • 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 7, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL 62% v/v

  • INACTIVE INGREDIENTS

    WATER, GLYCERIN, TRIETHANOLAMINE, CARBOMER, CITRUS LIMON (LEMON) FRUIT OIL, CAMELLIA SINENSIS LEAF EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CHAMAECYPARIS OBTUSA OIL, DISODIUM EDTA

  • PURPOSE

    ANTISEPTIC

  • 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 eyes 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.

  • Uses

    •Hand Sanitizers
    •instant hand antiseptic to decrease bacteria on the skin.

  • Directions

    • Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.
    • Supervise children in the use of this product.

  • Other information

    • Keep away from direct sunlight, ultra-high temperature, and ultra-low temperature
    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    THE KEEPS ETHANOL 62 PERCENT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74710-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CITRUS X LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74710-0010-21 in 1 CARTON07/01/2020
    1NDC:74710-0010-1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2020
    Labeler - THE GUNG CO LTD (688293532)
    Registrant - THE GUNG CO LTD (688293532)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woorilife&Health694860803manufacture(74710-0010)
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