Label: HAND SANITIZER 7- 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 June 6, 2020

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  • ACTIVE INGREDIENT

    alcohol

  • PURPOSE

    to decrease bacteria on the skin that could cause disease

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    take appropriate amount on the hand, rub and dry well

  • WARNINGS

    ■ Flammable. Keep away from fire or flame.

    ■ For external use only.

    ■ Do not use in eyes.

    ■ lf swallowed, get medical help promptly.

    ■ Stop use, ask doctor lf irritation occurs.

    ■ Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    for external use only

  • INACTIVE INGREDIENT

    Purified water, Ethanol, Glycerine, Triethyleneamine, Carbomer, Fragrance(lemon)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 7 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75695-0004
    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
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75695-0004-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/06/2020
    Labeler - Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch (695625894)
    Registrant - Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch (695625894)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch695625894manufacture(75695-0004)
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