Label: HAND SANITIZER- 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 June 1, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • Uses

    • helps reduce bacteria that potentially can cause disease
    • helps prevent cross contamination by hand contact
    • recommended for repeated use
  • Warnings

    For external use only.

    Flammable. Keep away from heat or flame

    Do not use

    • in children less than 2 months of age or on open skin wounds

    When using this product

    • Keep out of eyes and mouth.

         In case of contact with eyes, rinse eyes thoroughly with water

    Stop use and ask a doctor

    if irritation or redness develops.

    Keep out of reach of children.

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

  • Directions

    • Place enough product on hands to cover all surfaces.
    • Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • avoid freezing and excessive heat above 40°C (104°F)
    • may discolor certain fabrics
  • Inactive ingredients

    Water, Glycerin, Aloe Barbadensis Extract, Aminomethyl Propanol, Porpylene Glycol, Carbomer, Fragrance, Toopherol.

  • Package Labeling: 500ml

    Label

  • Package Labeling: 1000ml

    Label2

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78304-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78304-004-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/21/2020
    2NDC:78304-004-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/21/2020
    Labeler - BLAKEMORE SALES CORPORATION (164380578)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Huanyan Daily Chemical Products Co., Ltd554527491manufacture(78304-004)
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