Label: FRESH PURE HAND- alcohol gel

  • 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 November 11, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: ALCOHOL 70%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Butylene Glycol, Carbomer, Triethanolamine, Polysorbate 60, Isopropyl Myristate, Fragrance

  • PURPOSE

    Purpose: ANTISEPTIC

  • WARNINGS

    Warnings:

    Flammable, Keep away from fire or flame


    For external use only

    When using this product do not use in or near the eyes.
    In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or redness develops.

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Uses:

    For handwashing when water is not available to decrease bacteria on the skin
    - After changing diapers
    -  After assisting ill persons
    -  Before contact with a person under medical care or treatment
    -  Recommended for repeated use

  • Directions

    Directions:

    -  Apply palmful to hands
    -  Rub hands together vigorously until dry
    -  Supervise children in the use of this product

  • Other Information

    Other Information:
    Store at room temperature: 15°~30 °C (59°~86 °F)

  • PACKAGE LABEL - FRESH PURE HAND GEL 30mL * 20ea Carton

    Image of carton

  • PACKAGE LABEL - FRESH PURE HAND GEL 500mL Bottle

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    FRESH PURE HAND 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74004-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74004-030-0220 in 1 CARTON03/01/2020
    1NDC:74004-030-0130 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:74004-030-03500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2020
    Labeler - Ester Co., Ltd. (688425766)
    Registrant - Ester Co., Ltd. (688425766)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ester Co., Ltd.688425766manufacture(74004-030)
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