Label: FIRST HAND SANITIZER- 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 May 18, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL

  • INACTIVE INGREDIENT

    glycerin carbomer, green tea extract, aloe extract, mugwort extract, L-menthol, triethanolamine

  • PURPOSE

    SANITIZER

  • WARNINGS

    1.Do not use the product on the following areas:

    Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)

    2.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.

    1) Hypersensitivity symptoms, e.g. rash, erythema, itchiness, and edema

    2)Skin irritation symptoms

    3.Other precautions

    1) For external use only (do not swallow).

    2) Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.

    3)Be careful not to inhale vapors in cases of extended or prolonged use. (Repeating inhaling of large amounts of ethanol vapor may cause irritation of the mucous membranes and headaches).

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and go to the hospital immediately if swallowed.

  • Uses

    Disinfection of hands and skin

  • Directions

    Take an appropriate amount on your hands and rub thoroughly to dry.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FIRST HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74406-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74406-002-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/19/2020
    Labeler - Korea Life Science Co.,ltd (694914835)
    Registrant - Korea Life Science Co.,ltd (694914835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Korea Life Science Co.,ltd694914835manufacture(74406-002)
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