Label: HAND SANITIZER- alcohol aerosol, spray

  • NDC Code(s): 58133-959-66
  • Packager: Cosmetic Specialty Labs, Inc.
  • 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 August 30, 2021

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Aloe Barbadenis Leaf Juice.
    3. Caprylyl Glycol.
    4. Glycerin.
    5. Phenoxyethanol.
    6. Polysorate-20.
    7. Purified Water.
    8. Tocopheryl Acetate.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • 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

    Principal Display PanelNDC:58133-959-66

  • 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:58133-959-66178 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package08/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/30/2021
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-959) , label(58133-959) , pack(58133-959) , analysis(58133-959)
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