Label: HAND CLEANER- 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 April 21, 2020

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  • ACTIVE INGREDIENT

    alcohol

  • PURPOSE

    sterilization of hands, skin and so on

  • 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

    glycerin, isopropyl myristate, carbomer, trolamine, propylene glycol, acoe x, water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND CLEANER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75695-0001
    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
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75695-0001-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    2NDC:75695-0001-2300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    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(75695-0001)
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