Label: CHEMISPHERE 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 9, 2016

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 63%

  • PURPOSE

    Antimicrobial

  • Directions

    Wet hands with enough product to cover hands. Rub hands together and allow to dry.

    Children under 6 require adult supervision.

  • Warnings

    For external use only.

    Flammable. Keep away from heat and flame.

    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 and ask a doctor is irritation or rash develops.

  • INACTIVE INGREDIENT

    Water, Glycerin, Tocopheryl Acetate, T-Butyl Alcohol, Carbomer, Fragrance

  • INDICATIONS & USAGE

    Hand sanitizer to decrease bacterial on the skin.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    Hand saniziter

  • INGREDIENTS AND APPEARANCE
    CHEMISPHERE HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61034-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61034-001-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2016
    Labeler - Chemisphere Corp (071957146)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemisphere Corp071957146manufacture(61034-001)