Label: HAND CLEAN PLUS 100 S- ethanol liquid

  • 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 17, 2020

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  • Active Ingredient

    Ethanol (95%) 68%

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help decrease bacteria on the skin
    Recommended for repeated use.

  • Warnings

    For external use only.

    Flammable - Keep away from fire or flame

  • When using this product

    • Do not use in or near eyes.
    • In case of contact, rinse thoroughly with water.
  • Stop use and ask a doctor

    if irritation and redness develops.

  • Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply palmful to hands. Rub hands together vigorously until dry.
    • Supervise children in the use of this product.
  • Other information

    • Read the directions and warnings before use.
    • Do not use for other purpose. Store at 1-30ºC (33.8-86ºF)
  • Inactive ingredients

    Water, Glycerin, Dipropylene Glycol, Carbomer, Triethanolamine

  • Package Label - Principal Display Panel

    1000 mL NDC: 73330-0015-1

    1000ml label

    500 mL NDC: 73330-0015-2

    500ml label

    100 mL NDC: 73330-0015-3

    100ml label

  • INGREDIENTS AND APPEARANCE
    HAND CLEAN PLUS 100 S 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73330-0015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.68 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73330-0015-11000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:73330-0015-2500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
    3NDC:73330-0015-3100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - COSNINE Inc (694607163)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSNINE, INC.694607163manufacture(73330-0015)
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