Label: HAND SANITIZER- alcohol aerosol, spray

  • 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 3, 2023

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  • Active Ingredient

    SD Alcohol 40 75%

  • PURPOSE

    Antimicrobial

  • Use

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable. Keep away from fire or flame. For external use only.

  • WHEN USING

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughtly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Use enough product in your palm to cover hands and rub hands together biskly until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 110F (43C)
    • May discolor fabrics or surfaces
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Fragrance, Glycerin, Phenoxyethanol, Polysorbate-20, Purified Water, Tocopheryl Acetate.

  • Package Label - Principal Display Panel

    15 mL sprayer NDC: 58133-959-19

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-959
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-959-1915 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/03/2023
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-959)
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