Label: DR.HOMES HAND CLEAN- ethanol 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 January 18, 2021

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  • Active Ingredient

    Ethanol 70%

  • Purpose

    Antiseptic

  • Uses

    ■To help reduce bacteria on the skin

  • Warnings

    For external use only.

    Flammable, keep away from heat or flames.

  • When using this product

    keep away from eyes. In case of eye contact,

    rinse eyes with water.

  • Stop use and ask doctor if

    irritation and redness develop and persist.

  • Keep out of reach of children.

    Keep out of reach of children.

  • Directions

    ■ Apply a small amount in your palm and rub hands together briskly until dry.

    ■ Supervise children under 6 years in the use of product.

  • Other Information

    ■ Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    Water, Carbomer, Triethanolamine, Glycerin, Fragrance

  • Questions or Comments?

    Call 82-2-3470-8367

  • Package Label

    75615-0040-1 50ml

    75615-0040-2 60ml

    75615-0040-3 100ml

    75615-0040-4 200ml

    75615-0040-5 250ml

    75615-0040-6 300ml

    75615-0040-7 500ml

    75615-0040-8 5000ml

  • INGREDIENTS AND APPEARANCE
    DR.HOMES HAND CLEAN 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75615-0040
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75615-0040-150 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2021
    2NDC:75615-0040-260 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2021
    3NDC:75615-0040-3100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2021
    4NDC:75615-0040-4200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/19/2021
    5NDC:75615-0040-5250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/19/2021
    6NDC:75615-0040-6300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/19/2021
    7NDC:75615-0040-7500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/19/2021
    8NDC:75615-0040-85000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/19/2021
    Labeler - UI COSMETICS CO., LTD (688362189)
    Registrant - UI COSMETICS CO., LTD (688362189)
    Establishment
    NameAddressID/FEIBusiness Operations
    UI COSMETICS CO., LTD688362189manufacture(75615-0040)
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