Label: CLEAN TO CLEAN HAND SANITIZER- hand sanitizer 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 May 29, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Use

    • to decrease bacteria on the skin that could cause disease
  • Warnings

    For external use only : hands

    Flammable. Keep away from heat or flame.

  • WHEN USING

    • When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin
    • do not inhale or ingest
  • STOP USE

    Stop use and ask a doctor if

    • irritation and rash occurs. These may be signs of serious condition
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry
    • Children under 6 years should be supervised when using this product
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
    • Do not use on children under two months of age.
  • Inactive ingredients

    Water, Carbomer, Tromethamin, Glycerin, Propylene Glycol, Panthenol, Aloe Barbadensis Leaf, Sodium Hyalunate, Tocopheryl Acetate

  • Package Label - Principal Display Panel

    2mL LableOutbox

  • INGREDIENTS AND APPEARANCE
    CLEAN TO CLEAN HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73812-003
    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
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    WATER (UNII: 059QF0KO0R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73812-003-02100 in 1 BOX05/29/2020
    1NDC:73812-003-032 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/29/2020
    Labeler - LTP Global (694215916)
    Establishment
    NameAddressID/FEIBusiness Operations
    KOREA COSPACK CO.,LTD.689059789manufacture(73812-003)
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